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.

A-Line · Arterial Blood Sampling Kit → Anesthesiology

Name: A-Line
Brand: A-Line

1manufacturer

3catalogue 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 A-Line
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	2024-05-17

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, serial number
Packaging	Pack of 100

Catalogue Numbers

Catalogue numbers for A-Line
Catalogue number	Size	Status
3332-91-S		In distribution
3300-26-S		In distribution
3333-91-S		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
Atellica® VTR Syringes	SunMed Group Holdings, LLC	7
Blood Gas Sampler	Westmed, Inc.	7
Atellica® VTR Syringes	Westmed, Inc.	5

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.

A-Line