Duns Number:305682023
Device Description: Ambu SPUR II Adult Bag Res.
Catalog Number
520211010E
Brand Name
SPUR® II Adult Resuscitator
Version/Model Number
520211010E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 31, 2026
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
215a6869-340e-41f9-ac0a-70757704b6b1
Public Version Date
June 01, 2021
Public Version Number
2
DI Record Publish Date
April 13, 2021
Package DI Number
05707480145447
Quantity per Package
12
Contains DI Package
05707480145454
Package Discontinue Date
May 31, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |