FDA.report

C-MATT

Primary DI
00815073021995
Brand
C-MATT
Company
CASCO MANUFACTURING SOLUTIONS, INC.
Model
H10327
Catalog number
H10327
Device description
Affinity Birthing Bed U / Straight Foam Seat and Back Cover Only
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
FMWCOVER, MATTRESS (MEDICAL PURPOSES)

Product Code Classifications

CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815073021995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815073021995008150730219958150730219950815073021995

GMDN Terms

TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.

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

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07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850045714536Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-08-18
00840828194433BED COVER 8X36X86 P500 VC STEP DECK - PCCURBELL MEDICAL PRODUCTS, INC.FMW2025-08-11
00818323020403SuresVIVE HEALTH LLCFMW2025-07-09
00818323020410SuresVIVE HEALTH LLCFMW2025-07-09