Duns Number:025460908
Device Description: CIRCUIT-ADULT RESPIRATORY
Catalog Number
72R700200
Brand Name
Medline Industries, Inc.
Version/Model Number
72R700200
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
K925217,K925217
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
09a6e8da-6842-4837-b316-ab02bd098e03
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
May 12, 2019
Package DI Number
40193489692984
Quantity per Package
15
Contains DI Package
10193489692983
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 |