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

Deltran

Name: Deltran
Brand: Deltran

"INFANT DRAW" Disposable Pressure Transducer, Neonatal, 30cc/hr Flow Rate, Arterial Blood Collection System, 6cc Reservoir, For Use with Syringe Pumps, 24" Line

Registry build 21.09.26

1manufacturer

14catalogue 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 Deltran
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 10, box of 100

Catalogue Numbers

Catalogue numbers for Deltran
Catalogue number	Size	Status
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
II – PLUS	Flow Rate – 30 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS		In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
Cannula		In distribution
PLUS ABC KIT	Flow Rate – 3 cc/hr	In distribution
PLUS		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
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
Arterial Blood Sampling Kit	Utah Medical Products, Inc.	4

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.