What is FDA product code CBT?

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.

Anesthesiology › DiagnosticArterial Blood Sampling Kit

Atellica® VTR Syringes

Name: Atellica® VTR Syringes
Brand: Atellica® VTR Syringes

3mL Vented Luer Slip Syringe, 22g x 1" Needle, 50 IU/mL (~16.7 IU/mL) Balanced Heparin, Vented Tip Cap, Q-Cork

Registry build 21.09.26

1manufacturer

7catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code CBT
Manufacturer	City	Province	Registered as	Device types
Hantech Medical Device Co., Ltd.	Cixi	Zhejiang	Contract manufacturer	18

Record

Regulatory record for Atellica® VTR Syringes
Listed by	SunMed Group Holdings, LLC, United States
FDA product code	CBT
Device type	Arterial Blood Sampling Kit
Device class	Class 1
Regulation	21 CFR 868.1100
Establishment	Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2023-06-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 100

Catalogue Numbers

Catalogue numbers for Atellica® VTR Syringes
Catalogue number	Size	Status
11561349		In distribution
11561351		In distribution
11561343		In distribution
11561348		In distribution
11561352		In distribution
11561350		In distribution
11561342		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pulset	Westmed, Inc.	49
Medline	Medline Industries, Inc.	24
Centurion	Centurion Medical Products Corporation	22
Medex	ICU Medical, Inc	22
Regard™	Resource Optimization & Innovation, L.L.C.	16
AirLife™	Airlife, Inc.	16
Deltran	Utah Medical Products, Inc.	14
A-Line	Westmed, Inc.	12
Pulset	SunMed Group Holdings, LLC	11
Blood Gas Sampler	Westmed, Inc.	7
Atellica® VTR Syringes	Westmed, Inc.	5
Arterial Blood Sampling Kit	Utah Medical Products, Inc.	4

Showing 12 of 41. All products under Arterial Blood Sampling Kit

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2022-09-08	Class II	Process control	The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.	53,560 units	2024-06-18

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.