Duns Number:025460908
Device Description: CIRCUIT-ADULT ANESTHESIA
Catalog Number
72F1013-1-30
Brand Name
Medline/MMS Sales
Version/Model Number
72F1013-1-30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
CAI
Product Code Name
Circuit, breathing (w connector, adaptor, y piece)
Public Device Record Key
33316f70-e0b7-4bdf-9de0-767564e9bcf1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 2016
Package DI Number
20888277638331
Quantity per Package
20
Contains DI Package
10888277638334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cs
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 |