| Primary Device ID | 00709078008542 |
| NIH Device Record Key | cdbb3862-b4f8-4b01-936f-ebc1ddaf5392 |
| Commercial Distribution Discontinuation | 2023-08-11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breathing Bag |
| Version Model Number | 6395 |
| Company DUNS | 092673953 |
| Company Name | WESTMED, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00709078008542 [Primary] |
| BTC | Bag, Reservoir |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-08 |
| Device Publish Date | 2020-05-24 |
| 10709078004527 | Breathing Bag, 1/4 L (Non-Latex) |
| 00709078008528 | Breathing Bag, 2L, Not Made With Latex |
| 10709078011693 | Breathing Bag 1/2 Liters |
| 10709078011686 | Breathing Bag 2 Liter |
| 10709078004503 | Breathing Bag 1 Liter |
| 10709078011723 | Breathing Bag, 2L Not Made With Latex |
| 10709078011709 | Breathing Bag, 3L, Not Made With Latex, W/Norman Gas Elbow |
| 10709078010900 | Breathing Bag 3L, Not made with latex |
| 00709078008542 | Breathing Bag, 1/2L, Not Made With Latex |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BREATHING BAG 75154783 2125147 Dead/Cancelled |
Novalek, Inc. 1996-08-23 |