FDA.reportPublic FDA data

STR MAT-5X31X76-0T-STD FOAM-CAL117-PC

Primary DI
00840828163781
Brand
STR MAT-5X31X76-0T-STD FOAM-CAL117-PC
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
SM-53176-0T-SF117-PC
Catalog number
23030
Device description
STR MAT-5X31X76-0T-STD FOAM-CAL117-PC
Published
2020-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840828163781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828163781008408281637818408281637810840828163781

GMDN Terms#

Term, Definition table
TermDefinition
Bed mattress/cover setA collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196444GEN4 INTERACTIVE421384U-0709008307402026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESS5C050U-P10000288307442026-05-19
00840828196406GEN4 INTERACTIVE42119CU-0104018307102026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESS5C330U-Z10300011307092026-05-07
00840828196420800 S37,JE,BE,2L,790,BE ON 6&8BIC-19C0-A08-8307022026-05-07
00840828196437GEN4 INTERACTIVE437370U-0119728307152026-05-07
00840828196369GEN4 INTERACTIVE45331E-S14059F306952026-04-23
00840828196376GEN4 INTERACTIVE43719FU-0103018307002026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESS5C430U-Z3020000F307012026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESS5C422U-Z12700028307062026-04-23
00840828196338CALLCD,800,180,NO LOGO,WIRED FOR CACC180-986306882026-04-14
00840828196345RESPONDER 5, INTERACTIVE5I41JU-562427A306892026-04-14
00840828196352RESPONDER 5, INTERACTIVE5I41UU-801002A306922026-04-14
00840828196321SURELOCK, CURBELL/PHILIPS, BLUE, 10 PK989803209691306232026-04-09
00840828196284GEN4 INTERACTIVE410370E-0104468306862026-04-08
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PBMC-43688-CENPROPLUSTOP-PC306852026-04-08
00840828196246RESPONDER 5, INTERACTIVE5I414U-164031A306742026-04-01
00840828196253GEN4 INTERACTIVE45422U-S103028306802026-04-01
00840828196260GEN4 PLUS, DIRECT ACCESS5C19DU-Z15900178306762026-04-01
00840828196277GEN4 INTERACTIVE425331U-0150518306512026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
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