AccessGUDID - DEVICE: CARDINAL HEALTH (30885380112311)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 8831497
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8831497
Company Name: Cardinal Health 200, LLC

Primary DI Number: 30885380112311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: CHART PAPER, PHYSIO CONTROL 11240-000016

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):	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?
61901	Medical printer paper	A thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by a medical device (e.g., laboratory instrument/analyser, electrocardiograph, x-ray imaging system, hospital printer). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. 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 Humidity: between 45 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 106 Millimeter
Width: 30.48 Meter

Device Record Status

Public Device Record Key: 518dfa6d-82a1-4f3d-8a13-b9e90ff12931
Public Version Date: July 02, 2019
Public Version Number: 1
DI Record Publish Date: June 24, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50885380112315	12	30885380112311		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10885380112317 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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