AccessGUDID - DEVICE: Paper (20884838116430)

GUDID

Device Identifier (DI) Information

Brand Name: Paper
Version or Model: Thermal Array Paper
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M4816A
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838116430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Thermal Array Paper Chemical/thermal paper, 10 rolls/box, roll length = 98 ft. (29.9m), width = 1.97 in (50mm), weight = 2 lbs (907g).

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
Storage Environment Temperature: between -40 and 40 Degrees Celsius
Storage Environment Temperature: between -40 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e1daf6b0-d2cd-435d-9631-3b8394cc10d7
Public Version Date: January 06, 2025
Public Version Number: 2
DI Record Publish Date: December 18, 2024