FDA.report

NP50 Surface

Primary DI
00887761013124
Brand
NP50 Surface
Company
HILL-ROM, INC.
Model
P50A6F
Device description
Hospital Bed Surface
Published
2018-09-17
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

Contact Domains

Product Codes

CodeName
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887761013124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761013124008877610131248877610131240887761013124

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

Contacts

PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags

DUNS number
004245668
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
true
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
00615521012632ALLEN102001F-10001-F2023-05-26
00615521070069ALLENA-71103-US2026-02-27
00887761005419Dynamo Series StretcherP8001A2026-02-19
00887761005457Side rail PadP1465A2026-02-19
00887761010901Stretcher SurfaceP1461A1002026-02-19
00887761010918Stretcher SurfaceP1460A410002026-02-19
00887761010925Stretcher SurfaceP1460A510002026-02-19
00887761976542Experience PodP7546A012025-01-20
00887761007710Centrella™ SurfaceP7922A052024-11-27
00887761007727Centrella™ SurfaceP7922A072024-11-27
00887761007734Centrella™ SurfaceP7922A062024-11-27
00887761007741Centrella™ SurfaceP7922ARENT052024-11-27
00887761007758Centrella™ SurfaceP7922ARENT062024-11-27
00887761007765Centrella™ Surface2253742024-11-27
00887761966819Centrella™ Surface2103332024-09-20
00615521000820ALLEN1070021118932023-05-26
00615521000998ALLEN106002A-100152023-05-26
00615521001223ALLEN102001A-10052-L2023-05-26
00615521001230ALLEN102001A-10052-R2023-05-26
00615521001247ALLEN102001A-100562023-05-26

Other Devices Sharing Product Codes

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
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
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03