AccessGUDID - DEVICE: CARDINAL HEALTH (10885380168888)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: CA078170M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA078170M
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10885380168888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: CHB Lockbox 20, Custom for Munson

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?
15743	Specimen container mailer, insulated	A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNL	CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, NON-STERILE

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: 2284b472-1235-476e-9e6b-29b6fab1c9d5
Public Version Date: January 21, 2019
Public Version Number: 1
DI Record Publish Date: December 20, 2018