| Primary Device ID | 00084424900429 |
| NIH Device Record Key | e70c88f2-edae-440a-90b9-a6dcefdb0fd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hospitak, Resuscitator with Filter Adult, No Mask |
| Version Model Number | 880-E |
| Catalog Number | 880-E |
| Company DUNS | 809784593 |
| Company Name | CONVATEC, PURCHASING DEPARTMENT |
| 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 | false |
| Expiration Date | true |
| 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 | 00084424900429 [Primary] |
| GS1 | 20844249004238 [Package] Package: case [20 Units] In Commercial Distribution |
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-01 |
| Device Publish Date | 2015-10-15 |
| 10768455203946 - ESTEEM | 2024-09-23 N/A |
| 10768455209481 - ESENTA | 2024-09-03 ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR |
| 10768455209511 - ESENTA | 2024-09-03 ESENTA THIN CURVE 3X9CM (1X80PK) NAI |
| 00768455204793 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X30PK US |
| 00768455204823 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X30PK US |
| 00768455204854 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH14 1X30PK US |
| 00768455207145 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH10 1X10PK US |
| 00768455207169 - GENTLECATH | 2024-04-15 GENTLECATH AIR FEM V2.0 CH12 1X10PK US |