Primary Device ID | 00851978007627 |
NIH Device Record Key | 8be70ab7-dc9e-4863-9837-846f019851a5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | WoundPro+ Collection Canister |
Version Model Number | 8463540 0921 |
Company DUNS | 079262228 |
Company Name | Pensar Medical, LLC |
Device Count | 16 |
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 | 00851978007627 [Unit of Use] |
GS1 | 01085197800762 [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 | 2025-01-22 |
Device Publish Date | 2025-01-14 |
00851978007627 - WoundPro+ Collection Canister | 2025-01-22WoundPro+ 300cc Basic Collection Canister with 5 foot tubing, Case of 16 |
00851978007627 - WoundPro+ Collection Canister | 2025-01-22 WoundPro+ 300cc Basic Collection Canister with 5 foot tubing, Case of 16 |
00851978007634 - WoundPro+ 300cc Advanced Canister w/5' Tubing | 2025-01-22 WoundPro+ 300cc Advanced Canister w/5' Tubing, 16 per case |
00851978007603 - MicroDoc NPWT System | 2024-10-31 MicroDoc NPWT Dressing, 10cm x 50cm (5cm x 45cm) |
00851978007610 - MicroDoc NPWT System | 2024-10-31 MicroDoc NPWT System, each, with 10cm x 50cm (5cm x 45cm) Dressings |
00851978007580 - MicroDoc NPWT System | 2024-09-20 MicroDoc NPWT System, each, with 20cm x 25cm (15cm x 20cm) Breast Dressings |
00851978007597 - MicroDoc NPWT System | 2024-09-20 MicroDoc NPWT Breast Dressing, 20cm x 25cm (15cm x 20cm) |
00851978007559 - MicroDoc NPWT System | 2024-08-20 MicroDoc NPWT Dressing, 10cm x 20cm (5cm x 15cm) |
00851978007566 - MicroDoc NPWT System | 2024-08-20 MicroDoc NPWT Dressing, 10cm x 30cm (5cm x 25cm) |