AccessGUDID - DEVICE: Equipment Cover (00886333212828)

GUDID

Device Identifier (DI) Information

Brand Name: Equipment Cover
Version or Model: 399828A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 399828A
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333212828
Issuing Agency: GS1
Commercial Distribution End Date: January 20, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Equipment Cover 48" x 27"

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:	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?
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMP	Cover, Barrier, Protective

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 48" x 27" Equipment Cover

Device Record Status

Public Device Record Key: a337e582-42b9-4cf7-90a5-81d6f031b77a
Public Version Date: January 21, 2025
Public Version Number: 3
DI Record Publish Date: September 21, 2016