Primary Device ID | 00848530104993 |
NIH Device Record Key | d4a2377e-e51d-4ad2-bfda-853751f387e1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RESUSCITATION KIT |
Version Model Number | RES8100HNS |
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 | true |
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 |
Phone | 8775786738 |
customerservice@sunsethcs.com | |
Phone | 8775786738 |
customerservice@sunsethcs.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00848530104993 [Primary] |
CAE | Airway, Oropharyngeal, Anesthesiology |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-28 |
Device Publish Date | 2025-08-20 |
00848530105044 | Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit con |
00848530105037 | Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8 |
00848530104993 | Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs |