FDA.reportPublic FDA data

Extension mattress

Primary DI
04527799700325
Brand
Extension mattress
Company
PARAMOUNT BED CO., LTD.
Model
KA-H703EU
Device description
Mattress for tall users who use an extension frame.
Published
2020-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04527799700325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04527799700325045277997003254527799700325

GMDN Terms#

Term, Definition table
TermDefinition
Bed extensionA device intended to be use to increase the length of a bed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690552500
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04527799706549A6 Electrical Hospital Bed with Digital ScalePA-H6D582025-12-01
04527799706556A6 Electrical Hospital Bed with Digital ScalePA-H6D5C2025-12-01
04527799706563A6 Electrical Hospital Bed with Digital ScalePA-H6D5A2025-12-01
04527799706570A6 Electrical Hospital Bed with Digital ScalePA-H6D5B2025-12-01
04527799706624A6 Electrical Hospital Bed with Digital ScalePA-H6D682025-12-01
04527799706631A6 Electrical Hospital Bed with Digital ScalePA-H6D6C2025-12-01
04527799706648A6 Electrical Hospital Bed with Digital ScalePA-H6D6A2025-12-01
04527799706655A6 Electrical Hospital Bed with Digital ScalePA-H6D6B2025-12-01
04527799706709A6 Electrical Hospital Bed with Digital ScalePA-H6D58X2025-12-01
04527799706716A6 Electrical Hospital Bed with Digital ScalePA-H6D5CX2025-12-01
04527799706723A6 Electrical Hospital Bed with Digital ScalePA-H6D5AX2025-12-01
04527799706730A6 Electrical Hospital Bed with Digital ScalePA-H6D5BX2025-12-01
04527799706785A6 Electrical Hospital Bed with Digital ScalePA-H6D68X2025-12-01
04527799706792A6 Electrical Hospital Bed with Digital ScalePA-H6D6CX2025-12-01
04527799706808A6 Electrical Hospital Bed with Digital ScalePA-H6D6AX2025-12-01
04527799706815A6 Electrical Hospital Bed with Digital ScalePA-H6D6BX2025-12-01
04527799707188A6 Electrical Hospital BedPA-H6C182025-12-01
04527799707195A6 Electrical Hospital BedPA-H6C1C2025-12-01
04527799707201A6 Electrical Hospital BedPA-H6C1A2025-12-01
04527799707218A6 Electrical Hospital BedPA-H6C1B2025-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
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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
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
08592654851036Ergozone 3000L I N E T spol. s r.o.IKY2025-06-24
08592654851043Ergozone 5000L I N E T spol. s r.o.IKY2025-06-24
08592654851050Ergozone 7000L I N E T spol. s r.o.IKY2025-06-24
H933W84352910PK0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-04-03
08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
M676MC7WSTMLB0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNL2022-11-08
10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
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10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
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H93316745Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2021-05-28
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M368GS4054DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-06
M368GS3648B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
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