Duns Number:198227881
Device Description: Assurance Paper, cued with header, Smart format, 8.27 in. x 11 in. (210mm x 280mm) For use Assurance Paper, cued with header, Smart format, 8.27 in. x 11 in. (210mm x 280mm) For use with ELI280 and ELI 380. 250 sheets/pack, 12 packs/case. Price per case.
Catalog Number
9100-026-55
Brand Name
Welch Allyn, Inc.
Version/Model Number
901136
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
5dc9b2ea-8c47-4642-89dc-a67f310a00c1
Public Version Date
May 22, 2020
Public Version Number
1
DI Record Publish Date
May 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |