AccessGUDID - DEVICE: MediChoice (10885632120336)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: MST2008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632120336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Trap Specimen Mucous Vacuum Breaker With 8 French Catheter 20 Cubic Centimeter Polyurethane Sterile Not Made With Natural Rubber Latex MediChoice

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":	Yes
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?
10943	Sputum specimen container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	TRAP, STERILE SPECIMEN

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Protect from sunlight, protect from water damage

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3be3e932-b923-4037-85e8-ae4191feba0c
Public Version Date: June 16, 2021
Public Version Number: 1
DI Record Publish Date: June 08, 2021