AccessGUDID - DEVICE: NA (10841983103930)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: A/PA-1550Z
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A/PA-1550Z
Company Name: NIHON KOHDEN AMERICA, INC.

Primary DI Number: 10841983103930
Issuing Agency: GS1
Commercial Distribution End Date: August 15, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 021063219 *Terms of Use

Device Description: PAPER, ECG-1550A, 10 PADS

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):	Yes
Over the Counter (OTC):	No
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
DPS	ELECTROCARDIOGRAPH

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 816b9156-1c3a-475c-8858-9b8e2bf165d0
Public Version Date: August 17, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2016