What is FDA product code POQ?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General Hospital › TherapeuticBlood Transfusion Kit

Whole Blood Collection and Transfusion Kit

Name: Whole Blood Collection and Transfusion Kit
Brand: Whole Blood Collection and Transfusion Kit

Catalogue number 3425, listed by Altitude Technologies Inc., under Blood Transfusion Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code POQ
Manufacturer	City	Province	Registered as	Device types
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129

Record

Regulatory record for Whole Blood Collection and Transfusion Kit
Listed by	Altitude Technologies Inc.
FDA product code	POQ
Device type	Blood Transfusion Kit
Device class	Class 2
Regulation	21 CFR 880.5440
Premarket notification	Exempt
Record published	2018-05-15
Record revised	2023-06-13 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Whole Blood Collection and Transfusion Kit
Catalogue number	Size	Status
3425		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Curaplex	Bound Tree Medical, LLC	22
NAR	North American Rescue, LLC.	10
Valkyrie Ltowb Collection Set	Safeguard US Operating, LLC	8
Valkyrie Ltowb Administration Set	Safeguard US Operating, LLC	8
Fresh Whole Blood Transfusion Set	Safeguard US Operating, LLC	6
Forward	Synchronis Medical LLC	3
TMM-Fbtk-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise)	Altitude Technologies Inc.	1
TMM-LTC (Tactical Medical Module – Low Titer Collection)	Altitude Technologies Inc.	1
Mojo RFR First Responder Set	Safeguard US Operating, LLC	1
TMM-FBT-SOF (Tactical Medical Module – Field Blood Transfusion-Spec Ops Forces)	Altitude Technologies Inc.	1
Project Lavoy Blood Kit	Altitude Technologies Inc.	1
TMM-LTA (Tactical Medical Module-Low Titer Administration)	Altitude Technologies Inc.	1

Showing 12 of 14. All products under Blood Transfusion Kit

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.