FDA.reportPublic FDA data

KREG AIR, STAGE IV, LOW AIR LOSS, L/P, EZ WIDER

Primary DI
00850520008198
Brand
KREG AIR, STAGE IV, LOW AIR LOSS, L/P, EZ WIDER
Company
KREG MEDICAL INC.
Model
ASM100103
Device description
Hospital Bed Surface
Published
2018-09-21
Public version status
New
Distribution status
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
00850520008198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850520008198008505200081988505200081980850520008198

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattressA mattress-like device consisting of an arrangement of alternating-pressure air cells 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 is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 760-5734kmiudiInfo@kreg.us

Regulatory Flags#

DUNS number
079220324
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850520008280AP MAX MATTRESS SYSTEMASM2001042023-10-16
00850520008013OXYGEN TANK HOLDERASM1002172020-06-12
00850520008099EZ WIDER, FOOT WIDTH EXTENSION - RHASM2001142020-06-12
00850520008112EZ WIDER, FOOT WIDTH EXTENSION - LHASM2001152020-06-12
00850520008129EZ WIDER, FOOT LENGTH EXTENSIONASM1001062020-06-12
00850520008006SINGLE ARM TRAPEZE ASSEMBLYASM1001052018-09-21
00850520008020CATALYST BARIATRIC BEDASM1001122018-09-21
00850520008037THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM2001002018-09-21
00850520008044STAGE IV, LOW AIR LOSS, L/PASM2001112018-09-21
00850520008051EZ WIDER BARIATRIC BEDASM1001292018-09-21
00850520008068EZ WIDER BARIATRIC BEDASM1001002018-09-21
00850520008075EZ WIDER BARIATRIC BEDASM1001302018-09-21
00850520008082EZ WIDER BARIATRIC BEDASM1001042018-09-21
00850520008143CATALYST NON-EXPANDABLE BEDASM1001132018-09-21
00850520008150THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM1002022018-09-21
00850520008167THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEMASM1002032018-09-21
00850520008174VISCO MEMORY FOAM MATTRESS ASSEMBLYASM1001162018-09-21
00850520008181COMPOSURE MATTRESS ASSEMBLYASM1002042018-09-21
00850520008204COVERLET WITH ZIPPERASM1001172018-09-21
00850520008211COVERLET WITH ZIPPERASM1001182018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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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