Primary Device ID | 08033178109857 |
NIH Device Record Key | 4259a481-d0b5-4e40-a268-33e85b25796e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | D100/D101 |
Version Model Number | D633 HOLDER |
Company DUNS | 442126587 |
Company Name | SORIN GROUP ITALIA SRL |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08033178109857 [Primary] |
KRI | ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-01 |
Device Publish Date | 2023-10-24 |
08033178019361 - PROTEK SOLO | 2025-01-28 |
08033178019392 - PROTEK DUO+ | 2025-01-28 |
08033178019422 - PROTEK DUO+ | 2025-01-28 |
08033178019316 - PROTEK DUO+ | 2025-01-22 |
08033178019323 - PROTEK SOLO | 2025-01-22 |
08033178019330 - PROTEK SOLO | 2025-01-22 |
08033178019347 - PROTEK SOLO | 2025-01-22 |
08033178019354 - PROTEK SOLO | 2025-01-22 |