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.

Centurion · Arterial Blood Sampling Kit → Anesthesiology

Name: Centurion
Brand: Centurion

1manufacturer

22catalogue numbers in this listing

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 Centurion
Listed by	Centurion Medical Products Corporation, 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	2022-09-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Case of 20, case of 5, case of 12, case of 10, case of 15, case of 24
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Centurion
Catalogue number	Size	Status
ART1170		In distribution
DT12915		In distribution
ART975		In distribution
ART925		In distribution
ART195A		In distribution
ART695		In distribution
CVI4380A		In distribution
ART900		In distribution
CVI3580		In distribution
DT16780		In distribution
DT15670		In distribution
ART145		In distribution
CVI3370		In distribution
HT1755		In distribution
ART155A		In distribution
ART1050		In distribution
ART275		In distribution
DT15475		In distribution
DT16860		In distribution
ART160		In distribution
DT15915		In distribution
ART225		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
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
Arterial Blood Sampling Kit	Utah Medical Products, Inc.	4

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

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Centurion
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medline Industries, LP – Northfield	UDI-DI	2026-05-21	Class II	Nonconforming Material/Component	The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing in	5,698 kits
Medline Industries, LP – Northfield	UDI-DI	2026-03-16	Class II	Under Investigation by firm	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the	120 kits

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.

Centurion