FDA.report

C-MATT

Primary DI
00815073020004
Brand
C-MATT
Company
CASCO MANUFACTURING SOLUTIONS, INC.
Model
H12083
Catalog number
H12083
Device description
Versa Care Foam Replacement Mattress
Published
2019-04-05
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

Product Codes

CodeName
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815073020004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815073020004008150730200048150730200040815073020004

GMDN Terms

TermDefinition
Flame-resistant bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep; it is also designed to retard flames in case of fire. The device provides no special therapeutic effect.

Sterilization Methods

Method

Regulatory Flags

DUNS number
004253936
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815073029977CMATTH12698H126982022-06-06
00815073029991CMATTH12694H126942022-05-17
00815073029946CASCO21771217712022-01-14
00815073029953CMATTH12136-PH12136-P2022-01-14
00815073029939CMATTH12687H126872021-12-21
00815073029915CMATTH12686H126862021-11-30
00815073029908CMATTH10407H104072021-10-04
00815073029847CASCOH12677H126772021-08-24
00815073029854CASCOH12678H126782021-08-24
00815073029861CASCOH12679H126792021-08-24
00815073029878CASCOH12680H126802021-08-24
00815073029809CASCOH12673H126732021-08-20
00815073029816CASCOH12674H126742021-08-20
00815073029823CASCOH12675H126752021-08-20
00815073029830CASCOH12676H126762021-08-20
00815073029793CASCOH12672H126722021-08-19
00815073029786CASCOH12671H126712021-08-17
00815073029762CASCOH12669H126692021-08-16
00815073029779CASCOH12670H126702021-08-16
00815073029885CMATTH12441H124412021-08-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03