Duns Number:305682023
Device Description: SPUR II Pediatric Tube Res, No Wrap, PEEP
Catalog Number
531613071
Brand Name
SPUR® II Pediatric Resuscitator
Version/Model Number
531613071
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 28, 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
b13ddaf4-467f-4685-b5b9-3337d4865db3
Public Version Date
May 31, 2021
Public Version Number
2
DI Record Publish Date
January 31, 2020
Package DI Number
05707480143740
Quantity per Package
6
Contains DI Package
05707480143757
Package Discontinue Date
May 28, 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 |