FDA.report

Ever Proud

Primary DI
04527799700165
Brand
Ever Proud
Company
PARAMOUNT BED CO., LTD.
Model
KE-628UG
Device description
Bed mattress.
Published
2020-05-25
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
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04527799700165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04527799700165045277997001654527799700165

GMDN Terms

TermDefinition
Basic bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690552500
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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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05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
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H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
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H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
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