Duns Number:025460908
Device Description: ANESTHESIA CIRC W/SIZE 4 MASK
Catalog Number
DYNJAAF6726
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJAAF6726
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
CAI
Product Code Name
Circuit, breathing (w connector, adaptor, y piece)
Public Device Record Key
9b928ab5-fc14-49ff-b9df-ffd2986e6cb3
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
July 28, 2021
Package DI Number
40889942973751
Quantity per Package
20
Contains DI Package
10889942973750
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |