| Primary Device ID | 10889483002742 |
| NIH Device Record Key | c5e74c6c-44cb-457a-bed5-473876d46ecd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mask Harness |
| Version Model Number | 4-1054-22 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 | true |
| 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 | 10889483002742 [Primary] |
| BTK | Strap, Head, Gas Mask |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-27 |
| Device Publish Date | 2026-03-19 |
| 10889483002742 - Mask Harness | 2026-03-27STRAP, HEAD, GAS MASK |
| 10889483002742 - Mask Harness | 2026-03-27 STRAP, HEAD, GAS MASK |
| 30889483631472 - AirLife | 2026-03-09 AirLife Sterile Water for Inhalation, USP 1000ml with Spikeable Cap and Hanger |
| 20889483033309 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Infant |
| 20889483033316 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Child |
| 20889483033323 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Adult |
| 20889483230005 - VixOne™ | 2026-02-19 VixOne™ Nebulizer Mask Kit, Pediatric |
| 20889483300135 - Respan® | 2026-02-19 Disposable Anesthesia Breathing Circuit, 60" Adult Circuit, Parallel Wye, Gas Sampling Elbow |
| 30889483562615 - BALLARD™ | 2026-02-06 BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Endotracheal |