FDA.reportPublic FDA data

SLEEP SYSTEM NITETIME

Primary DI
05050962140530
Brand
SLEEP SYSTEM NITETIME
Company
THE HELPING HAND COMPANY (LEDBURY) LIMITED
Model
LOWER LIMB POSITIONING ITEMS
Catalog number
SA5540S
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
05050962140530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050962140530050509621405305050962140530

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
Premarket exempt
true
Lot or batch
true

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
05050962002036RAISED TOILET SEATUNI-FIXHA06002024-02-02
05050962001534EZY-ONEZY-ON SMALLHA08302024-02-02
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
34895262521519HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521471HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521488HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521495HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521501HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521518HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521525HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521532HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
06975575170189YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170196YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170202YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
05060631840548SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-21
05060631840005SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840012VoyagerSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840029Voyager CompactSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840500SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840517SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
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