Who else makes this device?

Anesthesiology › TherapeuticCatheter, Conduction, Anesthetic

ambIT* Introducer – Beveled Tip, Peelable Sheath

Catalogue number 220418, listed by Avanos Medical, Inc., United States, under Catheter, Conduction, Anesthetic. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2recalls on this code

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BSO
Manufacturer	City	Province	Registered as	Device types
Zhejiang Runqiang Medical Instruments Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	9

Record

Regulatory record for ambIT* Introducer – Beveled Tip, Peelable Sheath
Listed by	Avanos Medical, Inc., United States
FDA product code	BSO
Device type	Catheter, Conduction, Anesthetic
Device class	Class 2
Regulation	21 CFR 868.5120
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K102460
Record published	2022-11-04
Record revised	2023-06-22 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Packaging	Case of 10

Catalogue Numbers

Catalogue numbers for ambIT* Introducer – Beveled Tip, Peelable Sheath
Catalogue number	Size	Status
220418		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arrow	Teleflex Medical LLC	366
Epimed	Epimed International, Inc.	56
Avanos	Avanos Medical, Inc.	48
E-Cath Tsui	Pajunk Gmbh Medizintechnologie	47
Halyard	Avanos Medical, Inc.	34
Infiltralong	Pajunk Gmbh Medizintechnologie	25
E-Cath acc. Tsui	Pajunk Gmbh Medizintechnologie	21
E-Cath Plus acc. Tsui	Pajunk Gmbh Medizintechnologie	17
Epinaut	Imedicom Co., Ltd.	16
E-Cath® Plus Tsui®	Pajunk Gmbh Medizintechnologie	10
E-Cath® II Tsui®	Pajunk Gmbh Medizintechnologie	9
Spinaut-E	Imedicom Co., Ltd.	9

Showing 12 of 65. All products under Catheter, Conduction, Anesthetic

Recalls

2 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
2012-06-01	Class II	Use error	I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.	75 units	2013-06-25
2012-06-01	Class II	Use error	I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.	450 units	2013-06-25

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.