| Primary Device ID | 00848956004860 |
| NIH Device Record Key | 0af93a33-4600-4a8d-8d61-58826606ab26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Bulb & Bladder |
| Version Model Number | D30200-210S |
| Catalog Number | D30200-210S |
| Company DUNS | 057680480 |
| Company Name | HEALTHMARK INDUSTRIES CO., INC. |
| Device Count | 5 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848956004860 [Unit of Use] |
| GS1 | 10848956004867 [Primary] |
| FCY | Bulb, Inflation, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-01-12 |
| Device Publish Date | 2022-12-08 |
| 00848956006178 - Sterile Bulb & Bladder | 2023-09-04 |
| 00848956004860 - Disposable Bulb & Bladder | 2023-01-12 |
| 00848956004860 - Disposable Bulb & Bladder | 2023-01-12 |
| 00848956004921 - Protech ™ Trays | 2022-12-15 |
| 00848956004938 - Protech ™ Trays | 2022-12-15 |
| 00848956004945 - Protech ™ Trays | 2022-12-15 |
| 00848956004952 - Protech ™ Trays | 2022-12-15 |
| 00848956004969 - Protech ™ Trays | 2022-12-15 |
| 00848956004983 - Protech ™ Trays | 2022-12-15 INSTRU-TRAY AERATED 6.625W X 10.125L - GREEN |