Duns Number:092673953
Device Description: Pediatric Strapette™ with Small Tube Tackels
Catalog Number
-
Brand Name
Strapette
Version/Model Number
CP-4220
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
3ac48a57-fc90-486f-b933-7ee93167ed88
Public Version Date
July 05, 2021
Public Version Number
1
DI Record Publish Date
June 25, 2021
Package DI Number
10709078013062
Quantity per Package
40
Contains DI Package
00709078013065
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 746 |
2 | A medical device with a moderate to high risk that requires special controls. | 320 |