AccessGUDID - DEVICE: Medical Action Industries (10809160021675)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 80391
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 10809160021675
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 092364462 *Terms of Use

Device Description: No description.

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:	Yes
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?
47777	Intermittent urethral catheterization kit, non-sterile	A collection of non-sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. Because of the potential frequency of catheterization, the catheter will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFE) commonly known as Teflon, or glass], and possibly coated with an antibiotic to help prevent infection of the urinary tract. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OHR	Catheter care tray

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
Special Storage Condition, Specify: store at room temperature
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39a951c3-ec93-41ed-b1c8-23f3d2c14ee0
Public Version Date: March 03, 2021
Public Version Number: 3
DI Record Publish Date: August 20, 2016