Duns Number:025460908
Device Description: DBD-PAPER, THERMAL, Z-FOLD, 215MM X 280M
Catalog Number
MDS727371
Brand Name
Medline
Version/Model Number
MDS727371
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSF
Product Code Name
RECORDER, PAPER CHART
Public Device Record Key
a3339871-2767-4ab2-838f-81d9b7a11821
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 21, 2021
Package DI Number
20888277667362
Quantity per Package
8
Contains DI Package
10888277667365
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 |