Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2650089

FEI Number

2650089

Entity Name

Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company

City/State/Country

Manati, PR, US

Establishment Address

Road 686 Km 2.3 Bo. Tierras Nuevas, Manati, PR 00674, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BRISTOL-MYERS SQUIBB COMPANY (Owner Number: 9011194)

Owner / Operator Contact Address

3551 Lawrenceville Road, --, Lawrence Township, NJ 08648, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K821537

PMA Number

N/A

All Registered Proprietary Names

Norm-Ject

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-07-15

Official Correspondent

Sushama Bhuta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BRISTOL-MYERS SQUIBB COMPANY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2650089. Last updated year: 2026. Please use registration number 2650089 when referencing this establishment in official correspondence.