AccessGUDID - DEVICE: 50mm x 22m ECG Printer Paper (3/roll) (00681490595896)

GUDID

Device Identifier (DI) Information

Brand Name: 50mm x 22m ECG Printer Paper (3/roll)
Version or Model: 11240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11240-000013
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00681490595896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: PAPER-ELECTROCARDIOGRAM,RECORDING

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
36585	Patient monitoring system module, printing	A small unit dedicated to providing a print-out of patient related data, e.g., an electrocardiogram (ECG), blood pressure, haemoglobin oxygen saturation (SpO2). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer providing the information requested for the print-outs from this module.	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: 01de674a-ec55-4a0d-bcca-52dba425ed86
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016