FDA.reportPublic FDA data

Perfusion Clamp with Adaptor

Primary DI
23700911900932
Brand
Perfusion Clamp with Adaptor
Company
INSTITUT GEORGES LOPEZ
Model
PC715A
Device description
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
Published
2024-10-18
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
FKKClamp, Line

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKKClamp, LineGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23700911900932PackageGS115In Commercial Distribution
33700911900939PackageGS115In Commercial Distribution
53700911900933PackageGS14In Commercial Distribution
13700911900935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2370091190093223700911900932
3370091190093933700911900939
5370091190093353700911900933
1370091190093513700911900935

GMDN Terms#

Term, Definition table
TermDefinition
Kidney donor-organ preservation/transport perfusion setA collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
393146183
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700911901000Perfusion CannulaPCAN32026-05-11
13700911901017Perfusion CannulaPCAN52026-05-11
13700911901024Perfusion CannulaPCAN82026-05-11
13700911901055Perfusion CouplerPCO252025-05-26
13700911900577DCX Disposable CassetteDCX2025-05-26
23700911901052Perfusion CouplerPCO252025-05-26
13700911900928Perfusion Clamp with AdaptorPC1020A2024-10-18
13700911900935Perfusion Clamp with AdaptorPC715A2024-10-18
13700911900942Perfusion Clamp with AdaptorPC1025A2024-10-18
23700911900925Perfusion Clamp with AdaptorPC1020A2024-10-18
23700911900949Perfusion Clamp with AdaptorPC1025A2024-10-18
13700911900652PARAGON-W (UW solution)PRGNX/100052023-12-22
13700911900669PARAGON-W (UW solution)PRGNX/100062023-12-22
23700911900659PARAGON-W (UW solution)PRGNX/100052023-12-22
23700911900666PARAGON-W (UW solution)PRGNX/100062023-12-22
13700911900522BEL-GEN Cold Storage SolutionBEL-GEN/2000/US2022-07-21
13700911900591Waters IGL Cold Storage SolutionCSS/10002023-05-24
13700911900607Waters IGL Cold Storage SolutionCSS/20002023-05-24
13700911900621Perfusion ClampPC10202023-06-05
13700911900638Perfusion ClampPC10252023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414208233ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
57332414208238ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2025-02-10
13700911900928Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900935Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900942Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900925Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
23700911900949Perfusion Clamp with AdaptorINSTITUT GEORGES LOPEZFKK2024-10-18
13700911900621Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900638Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
13700911900645Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900628Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900635Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
23700911900642Perfusion ClampINSTITUT GEORGES LOPEZFKK2023-06-05
36641670011528rescuCLAMP™ Catheter Repair ClampCardiomed Supplies IncFKK2021-04-21
16641670011517rescuCLAMP™ Catheter Repair ClampCardiomed Supplies IncFKK2021-04-21
00852250006093Lifemed Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00852250006109Lifemed Coated Line ClampLIFEMED OF CALIFORNIAFKK2019-03-20
00085412025360NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
00085412070643ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412025365NABAXTER HEALTHCARE CORPORATIONFKK2019-03-15
50085412070648ULTRACLAMPBAXTER HEALTHCARE CORPORATIONFKK2019-03-15