THI PURGE LINE W/O VALVE, TX

Primary DI: B066491196A3
Brand: THI PURGE LINE W/O VALVE, TX
Company: NOVOSCI CORP.
Model: 491196-A
Catalog number: 491196-A
Device description: A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary byp
Published: 2015-10-09
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: true
Single use: false

Related Records

Contact Domains

novosci.com

Product Codes

Code	Name
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
KOC	Accessories, Blood Circuit, Hemodialysis

Product Code Classifications

Code	Device	Specialty	Class
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	2
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
B066491196A3	Package	HIBCC	25	In Commercial Distribution
B066491196A0	Primary	HIBCC	0

GMDN Terms

Term	Definition
Cardiopulmonary bypass system tubing set	A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Term

Definition

Cardiopulmonary bypass system tubing set

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Sterilization Methods

Method

Contacts

Phone	Email
800-854-0567	info@novosci.com

Regulatory Flags

DUNS number: 938289980
Device count: 1
DM exempt: false
Premarket exempt: true
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

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