What is FDA product code POR?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

General Hospital › TherapeuticParenteral Administration Kit

Subcutaneous Injection Supply Kit 2

Name: Subcutaneous Injection Supply Kit 2
Brand: Subcutaneous Injection Supply Kit 2

The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code POR
Manufacturer	City	Province	Registered as	Device types
Jiangsu Guangda Medical Material Group Co., Ltd.	Haian	Jiangsu	Contract manufacturer	32
Winner Medical Co., Ltd.	Shenzhen	Guangdong	Specification developer	25
Zhejiang Kindly Medical Devices Co., Ltd.	Wenzhou	Zhejiang	Contract manufacturer	16
Winner Medical (Chongyang) Co., Ltd.	Chongyang	Hubei	Contract manufacturer	13
Winner Medical (Hunan) Co., Ltd.	Changde	Hunan	Contract manufacturer	5

Record

Regulatory record for Subcutaneous Injection Supply Kit 2
Listed by	B. Braun Melsungen Aktiengesellschaft
FDA product code	POR
Device type	Parenteral Administration Kit
Device class	Class 2
Regulation	21 CFR 880.5440
Premarket notification	Exempt
Record published	2018-09-03
Record revised	2025-01-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 15 to 30 °C
Packaging	Pack of 6

Catalogue Numbers

Catalogue numbers for Subcutaneous Injection Supply Kit 2
Catalogue number	Size	Status
900-V2US01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Subcutaneous Injection Supply Kit	B. Braun Melsungen Aktiengesellschaft	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.