Perfusion Pack

Primary DI
10803622137751
Brand
Perfusion Pack
Company
LIVANOVA USA, INC.
Model
Perfusion Pack
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10803622137751PackageGS12In Commercial Distribution
00803622137754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362213775110803622137751
00803622137754008036221377548036221377540803622137754

GMDN Terms

TermDefinition
Cardiopulmonary bypass system tubing setA 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

Regulatory Flags

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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