Duns Number:305682023
Device Description: Ambu SPUR II Adult Bag Res. + PEEP valve
Catalog Number
520611074
Brand Name
SPUR® II Adult Resuscitator
Version/Model Number
520611074
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
9df2da48-351b-4eae-afff-d53db14485ba
Public Version Date
June 01, 2021
Public Version Number
2
DI Record Publish Date
June 24, 2020
Package DI Number
05707480145331
Quantity per Package
6
Contains DI Package
05707480145348
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 |