Bhagwati Medicare Devices

⚠️ Moderate Risk

FEI: 3012258001 • Amraiwadi, Ahmedabad • INDIA

FEI

FEI Number

3012258001

📍

Location

Amraiwadi, Ahmedabad

🇮🇳

Country

INDIA

🏢

Address

8, Maruti Industrial Estate, Nr, Sindhvai Mata Temple, C.T.M.- Ramol, Amraiwadi, Ahmedabad, India

Moderate Risk

FDA Import Risk Assessment

46.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/10/2016

Latest Refusal

6/10/2016

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

54.7×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

11829×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

328029×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

34129×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

50829×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
6/10/2016	78GBMCATHETER, URETHRAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	85HFWCLAMP, UMBILICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FPDTUBE, FEEDING	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73CAICIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80MRZACCESSORIES, PUMP, INFUSION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	85HFWCLAMP, UMBILICAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80OJAINTRAVENOUS EXTENSION TUBING SET	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80MRZACCESSORIES, PUMP, INFUSION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	74DTZOXYGENATOR, CARDIOPULMONARY BYPASS	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80JOLCATHETER AND TIP, SUCTION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73BYXTUBING, PRESSURE AND ACCESSORIES	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73CAFNEBULIZER (DIRECT PATIENT INTERFACE)	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73CAHFILTER, BACTERIAL, BREATHING-CIRCUIT	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80MRZACCESSORIES, PUMP, INFUSION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73BYGMASK, OXYGEN	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	74DWMAPPARATUS, SUCTION, PATIENT CARE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80MRZACCESSORIES, PUMP, INFUSION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	80MRZACCESSORIES, PUMP, INFUSION	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	73CATCANNULA, NASAL, OXYGEN	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78GBMCATHETER, URETHRAL	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/10/2016	78FPDTUBE, FEEDING	118NOT LISTED 3280FRNMFGREG 341REGISTERED 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bhagwati Medicare Devices's FDA import refusal history?

Bhagwati Medicare Devices (FEI: 3012258001) has 29 FDA import refusal record(s) in our database, spanning from 6/10/2016 to 6/10/2016.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bhagwati Medicare Devices's FEI number is 3012258001.

What types of violations has Bhagwati Medicare Devices received?

Bhagwati Medicare Devices has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Bhagwati Medicare Devices come from?

All FDA import refusal data for Bhagwati Medicare Devices is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.