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.

Other · Arterial Blood Sampling Kit → Anesthesiology

Name: Other
Brand: Other

1manufacturer

1catalogue number

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 Other
Listed by	Medline Industries, Inc., United States
FDA product code	CBT
Device type	Arterial Blood Sampling Kit
Device class	Class 1
Regulation	21 CFR 868.1100
Premarket notification	Exempt
Record published	2021-12-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 15
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Other
Catalogue number	Size	Status
P42453		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 Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Other
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2023-05-18	Class II	Device Design	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.	2590 units

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.

Other