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

Pulset Syringe With Sheathed Blunt Tip Cannula

Name: Pulset Syringe with Sheathed Blunt Tip Cannula
Brand: Pulset Syringe with Sheathed Blunt Tip Cannula

with ~15 Balanced Heprin

Registry build 21.09.26

1manufacturer

1catalogue number

14recalls on this code

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 Pulset Syringe with Sheathed Blunt Tip Cannula
Listed by	Westmed, 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, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2017-09-07
Record revised	2026-07-03 (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
Distribution end date	2026-05-05

Catalogue Numbers

Catalogue numbers for Pulset Syringe with Sheathed Blunt Tip Cannula
Catalogue number	Size	Per pack	Status
3100-31		100	Withdrawn

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

14 of these are 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
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22
2011-01-18	Class II	Material/Component Contamination	Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.	1,259,200 units total	2012-10-22

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.