Primary Device ID | 08033178103428 |
NIH Device Record Key | d0ac3625-9592-47b0-82a0-e05c7e8c6b45 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hemoconcentrator |
Version Model Number | 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 | 08033178103428 [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 |
38033178018648 - Suction tip | 2024-04-12 |
38033178018655 - Suction tip | 2024-04-12 |
38033178018662 - Suction tip | 2024-04-12 |
38033178018679 - Suction tip | 2024-04-12 |
38033178018709 - Suction tip | 2024-04-12 |
38033178018716 - Suction tip | 2024-04-12 |
38033178018723 - Suction tip | 2024-04-12 |
38033178018730 - Suction tip | 2024-04-12 |