Welch Allyn, Inc. - Assurance Paper, Z-fold pad, red grid, perforated - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: Assurance Paper, Z-fold pad, red grid, perforated with blank header, 8.5 in. x 11 in. (216 Assurance Paper, Z-fold pad, red grid, perforated with blank header, 8.5 in. x 11 in. (216mm x 279mm).For use with 8300/8500, Atria, Eclipse Plus/ Premier, and Quest. 200 sheets/pad, Price per pad.

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More Product Details

Catalog Number

716-0237-002

Brand Name

Welch Allyn, Inc.

Version/Model Number

901136

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DSF

Product Code Name

RECORDER, PAPER CHART

Device Record Status

Public Device Record Key

d09632de-58a2-4ad8-a41d-6662bb0faf19

Public Version Date

May 22, 2020

Public Version Number

1

DI Record Publish Date

May 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELCH ALLYN, INC." Characteristics
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