Primary Device ID | 10848530062207 |
NIH Device Record Key | e76d444d-d95d-43ae-90b5-384df652f81a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tracheostomy Tube Neckband with Fastener Tabs - Pediatric |
Version Model Number | RES029P |
Catalog Number | RES029P |
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 | 00848530062200 [Primary] |
GS1 | 10848530062207 [Package] Contains: 00848530062200 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 |
00848530060749 - Oxygen Cylinder Cart | 2025-05-29 Oxygen Cylinder Cart, Powder Coated, Adjustable Handle - For single tanks sizes E/D - 4/case |
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 |