Primary Device ID | 00815948021389 |
NIH Device Record Key | 2205cbe9-558e-4a7d-918c-cef0ec4c9e43 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | REAL Sensor Bands |
Version Model Number | BND |
Company DUNS | 191077671 |
Company Name | PENUMBRA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 | 00815948021389 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-06-08 |
Device Publish Date | 2020-06-17 |
00815948028029 - MIDWAY | 2024-04-10 MIDWAY 43 Delivery Catheter, 115cm, no CE |
00815948028036 - MIDWAY | 2024-04-10 MIDWAY 62 Delivery Catheter, 125cm, no CE |
00815948028159 - RED 43 | 2024-04-10 Reperfusion Catheter RED 43, 153cm, no CE |
00815948028166 - RED 43 | 2024-04-10 Reperfusion Catheter RED 43 Kit, 153cm, Jon Snow Tubing, no CE |
00815948028173 - RED 43 | 2024-04-10 Reperfusion Catheter RED 43 Kit, 153cm, 110 Tubing, no CE |
00815948028180 - MIDWAY | 2024-04-10 MIDWAY 43 Delivery Catheter, 125cm, No CE |
00815948028197 - MIDWAY | 2024-04-10 MIDWAY 62 Delivery Catheter, 115cm, no CE |
00815948029422 - Indigo System | 2024-03-29 CAT16 XTORQ 100cm, Select 135cm H1 Tip, Lightning Flash Tubing |