FDA.reportPublic FDA data

Perfusion Pack

Primary DI
00803622164378
Brand
Perfusion Pack
Company
LIVANOVA USA, INC.
Model
Perfusion Pack
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTNReservoir, blood, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920312000NEW COBE CARDIOPLEGIA SYSTEMCobe Cardiovascular, Inc.1992-10-01DTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622164375PackageGS18In Commercial Distribution
00803622164378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362216437510803622164375
00803622164378008036221643788036221643780803622164378

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood 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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622103001Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103018Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103025Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103032Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103049Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103056Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103063Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103070Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103087Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103094Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103117Cardioplegia cannulaAR-xxxxx2015-07-16
00803622103124Cardiopulmonary bypass cannula vent plugAX-xxxxx2015-07-16
00803622103131Cardiopulmonary bypass cannula vent plugAX-xxxxx2015-07-16
00803622103964Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622103971Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622103988Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622103995Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622104008Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622104015Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10
00803622104022Venous cardiopulmonary bypass cannulaLR-xxxxx2015-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117378264HORIZON 8AFEUROSETS SRLDTN2026-10-15
00803622164859Perfusion PackLIVANOVA USA, INC.DTN2026-09-29
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113145INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113152INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114073XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114080XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114097XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114103XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114110XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114127XTRASORIN GROUP ITALIA SRLDTN2024-12-20