AccessGUDID - DEVICE: Welch Allyn, Inc. (10817655021161)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901136
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9100-026-04
Company Name: WELCH ALLYN, INC.

Primary DI Number: 10817655021161
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Assurance Paper, cued with header 8.5 in x 11 in. For use with EL 250 and 250c, ELI 280, and ELI 350. 250 sheets/pack, 12 packs/case. Price per pack

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16754	Electrocardiographic recording paper	A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSF	RECORDER, PAPER CHART

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c930b2ed-8463-4e86-b036-5de759841d7a
Public Version Date: August 11, 2022
Public Version Number: 2
DI Record Publish Date: May 14, 2020