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

Arterial Blood Sampling Kit

Name: Arterial Blood Sampling Kit
Brand: Arterial Blood Sampling Kit

Arterial Blood Collection (ABC) System, Vacuum Collection Sampling System with Protected Cannula

Registry build 21.09.26

1manufacturer

4catalogue numbers in this listing

1510(k) clearance

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 Arterial Blood Sampling Kit
Listed by	Utah Medical Products, Inc., United States
FDA product code	CBT
Device type	Arterial Blood Sampling Kit
Device class	Class 1
Regulation	21 CFR 868.1100
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2016-09-23
Record revised	2019-12-18 (version 3)

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
Packaging	Box of 25, box of 50

Catalogue Numbers

Catalogue numbers for Arterial Blood Sampling Kit
Catalogue number	Size	Status
PLUS ABC KIT		In distribution
ACCESSORY		In distribution
Custom		In distribution
Custom		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K955663	1997-03-17

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.