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

Valkyrie Ltowb Collection Set

Name: Valkyrie Ltowb Collection Set
Brand: Valkyrie Ltowb Collection Set

VALKYRIE LTOWB COLLECTION SET Constricting Band (18" x 1") 1 ea Gauze Sponge (4" x 4") 2 ea Safety IV Cath 16G x 1.25" 2 ea Prevahex Transparent Dressing (4" x 4.75") 2 ea Blood Collection…

Registry build 21.09.26

VALKYRIE LTOWB COLLECTION SET Constricting Band (18″ x 1″) 1 ea Gauze Sponge (4″ x 4″) 2 ea Safety IV Cath 16G x 1.25″ 2 ea Prevahex Transparent Dressing (4″ x 4.75″) 2 ea Blood Collection Bag 1 ea Gloves (Pair) 1 ea Chlorhexidine Swab 2 ea 5.25″ Kelly Clamp 1 ea Needle Port 2 ea Beaded Cable Tie 1 ea Nylon Cord (10″) 1 ea ASBP 572 1 ea Blood Bag Label 1 ea Valkyrie TCCC Card 1 ea Instructions for Use 1 ea

1manufacturer

8catalogue numbers in this listing

5recalls on this code

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 Valkyrie Ltowb Collection Set
Listed by	Safeguard US Operating, LLC, United States
FDA product code	POQ
Device type	Blood Transfusion Kit
Device class	Class 2
Regulation	21 CFR 880.5440
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2022-08-22
Record revised	2022-05-02 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2028-05-31

Catalogue Numbers

Catalogue numbers for Valkyrie Ltowb Collection Set
Catalogue number	Size	Status
12		In distribution
11		In distribution
06		Withdrawn
02		Withdrawn
07		Withdrawn
04		Withdrawn
05		Withdrawn
01		Withdrawn

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 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
Whole Blood Collection and Transfusion Kit	Altitude Technologies Inc.	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

Recalls

5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-12-23	Class I	Process control	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	531 units	2024-07-09
2020-12-23	Class I	Process control	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	954 units	2024-07-09
2020-12-23	Class I	Process control	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	1021 units	2024-07-09
2020-12-23	Class I	Process control	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	27090 units	2024-07-09
2020-12-23	Class I	Process control	There is the potential of a bent or disconnected needle in one of the components of the convenience kits.	953 units	2024-07-09

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.