FDA.reportPublic FDA data

Immersus

Primary DI
00850016369161
Brand
Immersus
Company
IMMERSUS HEALTH COMPANY, LLC
Model
"Replacement Cover 42""x84""x6"""
Catalog number
2302
Device description
"2302 Replacement Cover for Immersus Mattress 42""x84""x6"""
Published
2020-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850016369161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016369161008500163691618500163691610850016369161

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080627691
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016369437Posture-Mate"HB 16"" System Complete"22212020-02-20
00850016369444Posture-Mate"HB 18"" System Complete"22252020-02-20
00850016369451Posture-Mate"HB 20"" System Complete"22292020-02-20
00850016369468Posture-Mate"HB 22"" System Complete"22332020-02-20
00850016369475Posture-Mate"WC 16"" System Complete"22372020-02-20
00850016369482Posture-Mate"WC 18"" System Complete"22382020-02-20
00850016369499Posture-Mate"WC 20"" System Complete"22392020-02-20
00850016369505Posture-Mate"WC 22"" System Complete"22402020-02-20
00850016369512Posture-MateG System Complete22172020-02-20
00850016369529Posture-MateG Seat & Calf Assembly only2217-SC2020-02-20
00850016369536Posture-MateG Universal Arm Pad only2217-A2020-02-20
00850016369543Posture-MateG Back & Head Pillow Assembly only2217-BH2020-02-20
00850016369550Posture-Mate"WC 22"" Seat Cushion only"2244-S2020-02-20
00850016369567Posture-Mate"WC 22"" Back Cushion only"2244-B2020-02-20
00850016369574Posture-Mate"WC 22"" Calf Pad only"2244-C2020-02-20
00850016369581Posture-Mate"WC 20"" Seat Cushion only"2242-S2020-02-20
00850016369598Posture-Mate"WC 20"" Back Cushion only"2243-B2020-02-20
00850016369604Posture-Mate"WC 20"" Calf Pad only"2243-C2020-02-20
00850016369611Posture-Mate"HB 16"" Head Cushion only"2218-H2020-02-20
00850016369628Posture-Mate"HB 18"" Head Cushion only"2222-H2020-02-20

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