Duns Number:072656713
Device Description: H&H Simplified Cric Kit, a one time use sterile emergency airway kit for opening an airway H&H Simplified Cric Kit, a one time use sterile emergency airway kit for opening an airway through the cricoid membrane.
Catalog Number
HHSCK01
Brand Name
H&H Simplified Cric Kit
Version/Model Number
Version 1
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"
-
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
OGP
Product Code Name
Cricothyrotomy Kit
Public Device Record Key
fd63a890-86c9-42c2-88aa-7bc459dc4798
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
10857048006498
Quantity per Package
10
Contains DI Package
00857048006491
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |