FDA.reportPublic FDA data

Perfusion Pack

Primary DI
00803622164668
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
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, 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
10803622164665PackageGS110In Commercial Distribution
00803622164668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362216466510803622164665
00803622164668008036221646688036221646680803622164668

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
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22
00803622164514Perfusion PackPerfusion Pack2026-09-22
00803622164569Perfusion PackPerfusion Pack2026-09-22
00803622164576Perfusion PackPerfusion Pack2026-09-22
00803622164583Perfusion PackPerfusion Pack2026-09-22
00803622164590Perfusion PackPerfusion Pack2026-09-22
00803622164606Perfusion PackPerfusion Pack2026-09-22
00803622164613Perfusion PackPerfusion Pack2026-09-22
00803622164699Perfusion PackPerfusion Pack2026-09-22
00803622164750Perfusion PackPerfusion Pack2026-09-22
00803622164286Perfusion PackPerfusion Pack2026-08-25
00803622164316Perfusion PackPerfusion Pack2026-08-25
00803622164323Perfusion PackPerfusion Pack2026-08-25
00803622164040Perfusion PackPerfusion Pack2026-07-30
00803622163982Perfusion PackPerfusion Pack2026-07-17
00803622164071Perfusion PackPerfusion Pack2026-07-17
00803622164118Perfusion PackPerfusion Pack2026-07-17
00803622163623Perfusion PackPerfusion Pack2026-07-10
00803622163906Perfusion PackPerfusion Pack2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622164477Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164514Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164569Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164576Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164583Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164590Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164606Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164613Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164699Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164750Perfusion PackLIVANOVA USA, INC.DWE2026-09-22
00803622164286Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164316Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164323Perfusion PackLIVANOVA USA, INC.DWE2026-08-25
00803622164040Perfusion PackLIVANOVA USA, INC.DWE2026-07-30
00803622164071Perfusion PackLIVANOVA USA, INC.DWE2026-07-17
00803622164118Perfusion PackLIVANOVA USA, INC.DWE2026-07-17
00803622164019Perfusion PackLIVANOVA USA, INC.DWE2026-06-26
H965252810AngioVacNAVILYST MEDICAL, INC.DWE2020-05-11
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0061625800851630” (76 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800852320” (50 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
0061625800853010” (25 cm) High Pressure Connector TubeBAYER MEDICAL CARE INC.DWE2016-12-05
00643169137653NAMEDTRONIC, INC.DWE2016-07-23
00613994352811Intersept®MEDTRONIC, INC.DWE2016-06-17
00643169169593NAMEDTRONIC, INC.DWE2016-06-11
00643169019287INTERSEPT®MEDTRONIC, INC.DWE2016-06-06
00643169029293NAMEDTRONIC, INC.DWE2016-06-06
00613994363220Intersept®MEDTRONIC, INC.DWE2016-05-28
00613994363237Intersept®MEDTRONIC, INC.DWE2016-05-28