AccessGUDID - DEVICE: Medical Action Industries (10809160283721)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Action Industries
Version or Model: 81087
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDICAL ACTION INDUSTRIES INC.

Primary DI Number: 10809160283721
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2020
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:	Yes
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?
61949	Personal care kit	A collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSB	Patient personal hygiene kit

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:
Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e23d9e5-51c2-4dd4-a7b6-cd5d4f3d5012
Public Version Date: November 05, 2020
Public Version Number: 2
DI Record Publish Date: May 12, 2020