Primary Device ID | 20848530082073 |
NIH Device Record Key | 0dfb3952-d1df-43de-a64f-a3c86c78d7ee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr |
Version Model Number | TRATK110 |
Catalog Number | TRATK110 |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530082079 [Primary] |
GS1 | 10848530082076 [Package] Contains: 00848530082079 Package: [50 Units] In Commercial Distribution |
GS1 | 20848530082073 [Package] Contains: 10848530082076 Package: [4 Units] In Commercial Distribution |
OFS | Tracheal Suction Set |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-18 |
Device Publish Date | 2018-09-17 |
00848530107277 - Oxygen Kit | 2025-08-29 Oxygen Kit - This kit contains: RES1107S (4), RES3025G (2), RES037 (2), RES018 (2), RES003 (2), RES050 (2), and RES002 (1) |
00848530104993 - RESUSCITATION KIT | 2025-08-28 Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs |
00848530105006 - RESUSCITATION ACCESSORY | 2025-08-28 Sunset Disposable PEEP Valve, 5-20cm H20, 15mm ID |
00848530105013 - RESUSCITATION ACCESSORY | 2025-08-28 Sunset Disposable Pressure Manometer, L-Shape - 25PCS |
00848530105037 - RESUSCITATION KIT | 2025-08-28 Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8100H, 1SBC01M, 1SBC01L, RES8205B |
00848530105044 - RESUSCITATION KIT | 2025-08-28 Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit contains: 1 RES8110H, 1 SBC01S, 1S |
10848530107243 - Oxygen Connector/Adapter | 2025-08-27 Sunset Step-Down Tubing Adaptor 5-9mmOD; 22mmID |
10848530107281 - Heat Moisture Exchanger | 2025-08-27 Sunset Adult In-line Large Volume HME with Gas Sampling Port |