Duns Number:305682023
Device Description: SPUR II Adult Bag Res., OXYGEN Label, Med. Mask, PEEP
Catalog Number
520611072
Brand Name
SPUR® II Adult Resuscitator
Version/Model Number
520611072
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 27, 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
e9655f2e-6a1f-484e-a942-425ba1ba1764
Public Version Date
May 28, 2021
Public Version Number
2
DI Record Publish Date
May 19, 2020
Package DI Number
05707480143870
Quantity per Package
6
Contains DI Package
05707480143887
Package Discontinue Date
May 27, 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 |