Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024508819

FEI Number

3024508819

Entity Name

embecta medical I LLC

City/State/Country

Holdrege, NE, US

Establishment Address

1329 West Highway 6, Holdrege, NE 68949, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

embecta Corp. (Owner Number: 10084714)

Owner / Operator Contact Address

300 Kimball Drive, Parsippany, NJ 07054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212499

PMA Number

N/A

All Registered Proprietary Names

BD SafetyGlide BD SafetyGlide Insulin Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2022-10-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-10-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-10-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2022-10-19

Official Correspondent

Heather Reed

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

embecta Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027605735	embecta Medical Devices (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3023359743	embecta Penel Limited	Dun Laoghaire Co. Dublin, IE
3022699058	Embecta Medical II LLC	Parsippany, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024508819. Last updated year: 2026. Please use registration number 3024508819 when referencing this establishment in official correspondence.