FDA.reportPublic FDA data

SLEEP SYSTEM NITETIME

Primary DI
05050962293717
Brand
SLEEP SYSTEM NITETIME
Company
THE HELPING HAND COMPANY (LEDBURY) LIMITED
Model
LEG WRAPS MEDIUM
Catalog number
SA5531US
Device description
SLEEP SYSTEM NITETIME
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05050962293717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050962293717050509622937175050962293717

GMDN Terms#

Term, Definition table
TermDefinition
Assistive sleeping cushion setA collection of cushions, pads, pillows and bolsters intended to provide support and optimal positioning for a disabled person during sleep. The items are typically made of soft textile or synthetic materials and include pieces designed for specific body parts (e.g., head, shoulders, back, hips, knees, feet) used during different sleeping positions (supine, side, or prone lying). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401531638016johnwalters@helpinghand.co.uk

Regulatory Flags#

DUNS number
397307240
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050962423428SYMMETRISEAT 70FULLY POWERED SKTFP2024-10-17
05050962423435SYMMETRISEAT 70MANUALSKTMA2024-10-17
05050962423442SYMMETRISEAT 70SINGLE POWEREDSKTSP2024-10-17
05050962446670SYMMETRISEAT 50 50 MANUAL CHAIR SKMA10002024-10-17
05050962449138SYMMETRISEAT 50FULL POWER SKMA11002024-10-17
05050962449633SYMMETRISEAT 50 FULL POWER + KIT SKMA12002024-10-17
05050962001534EZY-ONEZY-ON SMALLHA08302024-02-02
05050962002036RAISED TOILET SEATUNI-FIXHA06002024-02-02
05050962011670SMALL TILTRITE MANUAL STANDARD BACKSTMST2024-02-02
05050962011687SMALL TILTRITE MANUAL SYMMETRIFORM BACKSTMSY2024-02-02
05050962013520SLEEP SYSTEM NITETIME 'A' CUSHION_SPECIALSA792024-02-02
05050962023048LEG-UPLEG-UP BLACK 26INHA09702024-02-02
05050962028838AVANTITALL FLAT-ARM HIGH-BK FT-PLSKLX00152024-02-02
05050962028845AVANTITALL FLAT-ARM LOW-BK FT-PLSKLX00252024-02-02
05050962028852AVANTITALL PAD-ARM HIGH-BK FT-PLSKLX00352024-02-02
05050962028869AVANTITALL PAD-ARM LOW-BK FT-PLSKLX00452024-02-02
05050962028913AVANTISHRT PAD-ARM LOW-BK FT-PLSKLX00852024-02-02
05050962031241SLEEP SYSTEM NITETIME POSITIONING BRACKET PADSA7192024-02-02
05050962057791SOXONSOXONHA09802024-02-02
05050962080065LEG-UPLEG-UP YELLOW 26INHA09652024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
B773KMHBD0KLYOKLYO MEDICAL SYSTEMS INC.FNJ2024-02-23
05050962013520SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962031241SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140530SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140622SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140646SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962140691SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962170971SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171947SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171985SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962171992SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962172005SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962174184SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962177246SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962177253SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962207929SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962252110SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962253773SLEEP SYSTEM NITETIME THE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02
05050962256378SLEEP SYSTEM NITETIMETHE HELPING HAND COMPANY (LEDBURY) LIMITEDFNJ2024-02-02