AccessGUDID - DEVICE: NA (10810030860829)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: MCM258
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCM258
Company Name: MID CENTRAL MEDICAL CORP.

Primary DI Number: 10810030860829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076907973 *Terms of Use

Device Description: Urinal Bag Hook. Designed to mounts low on the pole for Foley catheter bag. Fits most 1 inch IV poles. Durable stainless steel construction.

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):	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?
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion

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
Length: 3.75 Inch
Width: 3.75 Inch
Height: 2.75 Inch

Device Record Status

Public Device Record Key: 64313a9e-0675-4e0d-9a12-5e19442e593c
Public Version Date: September 25, 2020
Public Version Number: 2
DI Record Publish Date: September 15, 2020