Quantum SuperPAC Tubing set - SP07C-DA

GUDID 18051160302755

SPECTRUM MEDICAL SRL

Cardioplegia solution administration kit
Primary Device ID18051160302755
NIH Device Record Keyb4b19d05-d124-4d7f-94e8-db499956182a
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum SuperPAC Tubing set - SP07C-DA
Version Model NumberSP07C-DA
Company DUNS436188505
Company NameSPECTRUM MEDICAL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118051160302755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

Devices Manufactured by SPECTRUM MEDICAL SRL

18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA2024-08-20
18051160302755 - Quantum SuperPAC Tubing set - SP07C-DA2024-08-20
18051160302816 - Quantum SuperPAC Tubing set - SP07C-AA2024-08-20
18051160302830 - Quantum SuperPAC Tubing set - SP08C-AA2024-08-20
18051160302847 - Quantum SuperPAC Tubing set - SP09C-DA2024-08-20
18051160302854 - Quantum SuperPAC Tubing set - SP09C-AA2024-08-20
28051160302462 - KIT Quantum SuperPAC Tubing Set - 2002024-08-20
28051160302479 - KIT Quantum SuperPAC Tubing Set - 1602024-08-20
28051160302509 - KIT Quantum SuperPAC Tubing Set - 200R2024-08-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.