| Primary Device ID | 10848530062245 |
| NIH Device Record Key | b7330bb7-bbf9-471b-ac13-f46f0c4ae890 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric |
| Version Model Number | RES030P |
| Catalog Number | RES030P |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530062248 [Primary] |
| GS1 | 10848530062245 [Package] Contains: 00848530062248 Package: [20 Units] In Commercial Distribution |
| CBH | Device, Fixation, Tracheal Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
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| 00848530093839 - Cough Assist Kit | 2025-05-29 Trach Kit 1 kit contains: RES014 (1 each), BF2200 (1 each), TUB06 (1 each) |
| 00848530096137 - Nebulizer Kit | 2025-05-29 Compressor Nebulizer Kit 1 kit contains T-Piece, 7ft Supply Tube, 6in Aerosol Tube, and Jet Nebulizer |
| 00848530097363 - Limb Elbow | 2025-05-29 Single Limb Elbow |
| 00848530099640 - Tracheostomy and Suction Accessory | 2025-05-29 Suction Canister Disposable 1200CC - 48/Case |
| 00848530105327 - SpO2 Sensor | 2025-05-29 Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable |
| 00848530106119 - Pediatric Cannula | 2025-05-29 Pediatric Soft Cannula with 7ft. Supply Tube, Universal Connector |
| 00848530106126 - Infant Cannula | 2025-05-29 Infant Soft Cannula with 7ft. Supply Tube, Universal Connector |