Duns Number:305682023
Device Description: SPUR II Inf Bag, Pop, Neo & Inf Mask, Mano, PEEP, Exp Filter
Catalog Number
540216051
Brand Name
SPUR® Infant Resuscitator
Version/Model Number
540216051
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
-
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
8000970d-db28-456b-a7bb-475f9deb0401
Public Version Date
September 28, 2021
Public Version Number
1
DI Record Publish Date
September 20, 2021
Package DI Number
05707480154241
Quantity per Package
12
Contains DI Package
05707480154258
Package Discontinue Date
-
Package Status
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 |