AccessGUDID - DEVICE: Chart, X-Ref Godart Statham 13641, 11.75" x 60' (00817081025569)

GUDID

Device Identifier (DI) Information

Brand Name: Chart, X-Ref Godart Statham 13641, 11.75" x 60'
Version or Model: Chart, X-Ref Godart Statham 13641 - 135600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 135600
Company Name: A-M SYSTEMS, LLC

Primary DI Number: 00817081025569
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020275145 *Terms of Use

Device Description: Chart, X-Ref Godart Statham 13641, 11.75" x 60'

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:	Yes
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?
34937	Paper chart recorder	A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder.	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: 026c2645-3860-4535-a001-6a3fc0d446cd
Public Version Date: March 31, 2020
Public Version Number: 1
DI Record Publish Date: March 23, 2020