Primary Device ID | 00851978007412 |
NIH Device Record Key | e4542c7f-d3db-4ec2-8f65-67d0bd029208 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WoundPro Basic Series Y-Connector |
Version Model Number | 8463540 0674 |
Company DUNS | 079262228 |
Company Name | Pensar Medical, LLC |
Device Count | 10 |
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 | 00851978007412 [Unit of Use] |
GS1 | 10851978007419 [Primary] |
OMP | Negative Pressure Wound Therapy Powered Suction Pump |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-18 |
Device Publish Date | 2022-10-10 |
00851978007153 - MicroDoc NPWT Control Unit | 2022-10-20 MicroDoc NPWT Systems, 5 per box |
00851978007429 - Advanced Series Y-Connector | 2022-10-19 Advanced Series Y-Connector, 10 per case |
00851978007245 - Basic Series Hydrophobic Dressing Kit, Large | 2022-10-18 Basic Series Hydrophobic Dressing Kit, Large, Case of 10 |
00851978007269 - Advanced Series Hydrophobic Dressing Kit, Medium | 2022-10-18 Advanced Series Hydrophobic Dressing Kit, Medium, 10 per case |
00851978007276 - Advanced Series Hydrophobic Dressing Kit, Large | 2022-10-18 Advanced Series Hydrophobic Dressing Kit, Large, 10 per case |
00851978007382 - Basic Series StingRay Suction Bell | 2022-10-18 Basic Series StingRay Suction Bell, 10 per case |
00851978007399 - Advanced Series StingRay Suction Bell | 2022-10-18 Advanced Series StingRay Suction Bell, 10 per box |
00851978007405 - Mini StingRay | 2022-10-18 Mini StingRay, 10 per box |