FDA.report

Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats

Primary DI
00690521011663
Brand
Batrik Blue Cloud-Gel Anti-Fatigue Floor Mats
Company
Batrik Medical Manufacturing Inc
Model
800-4802
Catalog number
800-4802
Device description
Blue Cloud-GelTM Anti-Fatigue Mat, 20" x 48" (51 cm x 122 cm)
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690521011663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521011663006905210116636905210116630690521011663

GMDN Terms

TermDefinition
Anti-fatigue floor matA 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature and away from direct sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags

DUNS number
243880700
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00690521015876Batrik Your First Check17-22217-2222025-07-11
00690521025202EcoZyme First Touch19560-TS19560-TS2025-07-11
00690521025233EcoZyme First Touch19560-FS19560-FS2025-07-11
00690521025264EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025288EcoZyme First Touch19560-TS22019560-TS2202025-07-11
00690521025301EcoZyme First Touch19560-FS50019560-FS5002025-07-11
00690521025325EcoZyme First Touch19560-FS22019560-FS2202025-07-11
00690521025332EcoZyme First Touch19560-TS-BAG19560-TS-BAG2025-07-10
00690521019201Batrik ShoozCovers™ SC-1216-PDBSC-1216-PDB2025-02-14
00690521019218Batrik ShoozCovers™ SC-1226-PDBSC-1226-PDB2025-02-14
00690521020948Batrik ShoozCovers™ SC-1210-PBSC-1210-PB2025-02-14
00690521020955Batrik ShoozCovers™ SC-1616-PDBSC-1616-PDB2025-02-14
00690521020986Batrik ShoozCovers™ SC-1216-PBSC-1216-PB2025-02-14
00690521021365Batrik ShoozCovers™ SC-1226-PBSC-1226-PB2025-02-14
00690521021396Batrik ShoozCovers™ SC-1616-PBSC-1616-PB2025-02-14
00690521021419Batrik ShoozCovers™ SC-1922-PDBSC-1922-PDB2025-02-14
00690521021426Batrik ShoozCovers™ SC-1922-PBSC-1922-PB2025-02-14
00690521022683Batrik ShoozCovers™ SC-2112-NPBSC-2112-NPB2025-02-14
00690521022690Batrik ShoozCovers™ SC-2122-NPBSC-2122-NPB2025-02-14
00690521022881Batrik ShoozCovers™ SC-1220-PBSC-1220-PB2025-02-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05060624123696CS Align Pro Support - Replacement PadsCARE SURGICAL LIMITEDCCX2026-03-23
05060624126970CS Align Pro SupportCARE SURGICAL LIMITEDCCX2026-03-23
00850055249066Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249134Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249141Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249165Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249172Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249189Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249196Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249202Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249219Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249318Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249325Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249332Prime Medical LLCPrime Medical LLCCCX2026-03-05
05060624127182CS Easy Prone (170 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CARE SURGICAL LIMITEDCCX2026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CARE SURGICAL LIMITEDCCX2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
00199972000184CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000191CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000207CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000214CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
50749756401352DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22
50749756401376DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22