AccessGUDID - DEVICE: Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats (00690521011618)

GUDID

Device Identifier (DI) Information

Brand Name: Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats
Version or Model: 800-2401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-2401
Company Name: Batrik Medical Manufacturing Inc

Primary DI Number: 00690521011618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243880700 *Terms of Use

Device Description: Blue Cloud-GelTM Anti-Fatigue Mat, 18" x 24" (46 cm x 61 cm)

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:	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?
64493	Anti-fatigue floor mat	A pad designed to be stood on by healthcare staff to reduce fatigue associated with standing for prolonged periods (e.g., during procedures). It is designed to cushion the feet of the user and may include additional secondary features (e.g., non-slip, antimicrobial surface). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	Support, Patient Position

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at ambient temperature and away from direct sunlight
Special Storage Condition, Specify: Store at ambient temperature and away from direct sunlight
Special Storage Condition, Specify: Store at ambient temperature and away from direct sunlight
Special Storage Condition, Specify: Store at ambient temperature and away from direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de145513-1b8e-45cb-9017-752b55000fff
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020