Primary Device ID | 05707480042548 |
NIH Device Record Key | 112611b8-38bb-4fc7-9b02-a8b0628bcb7a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sleepmate / SparepartBody Position Band |
Version Model Number | 815000-000 |
Catalog Number | 815000-000 |
Company DUNS | 305682023 |
Company Name | Ambu A/S |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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 | true |
OTC Over-The-Counter | false |
Phone | +14107686464 |
Purchase_orders@ambuUSA.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05707480042548 [Primary] |
LXJ | System, optical position/movement recording |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-04 |
Device Publish Date | 2019-01-10 |
05707480157136 - Ambu® aScope™ Duodeno 2 | 2024-07-29 Duodenoscope |
05707480006540 - Immobilization Kit, with | 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult |
05707480006557 - Immobilization Kit, with | 2024-07-22 Ambu® Mini Perfit ACE™ and Ambu® Head Wedge™, Small Pediatric and Pediatric |
05707480037308 - Immobilization Kit, with | 2024-07-22 Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult |
05707480038626 - Immobilization Kit, with | 2024-07-22 Ambu® Military Perfit ACE™ and Ambu® Military Head Wedge™, Adult |
05707480006601 - Silicone Face Mask | 2024-07-16 Reusable face mask |
05707480006625 - Silicone Face Mask | 2024-07-16 Reusable face mask |
05707480006632 - Silicone Face Mask | 2024-07-16 Reusable face mask |