FDA.report

SLEEP SYSTEM NITETIME

Primary DI
05050962013520
Brand
SLEEP SYSTEM NITETIME
Company
THE HELPING HAND COMPANY (LEDBURY) LIMITED
Model
'A' CUSHION_SPECIAL
Catalog number
SA79
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

Related Records

Contact Domains

Product Codes

CodeName
FNJBed, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05050962013520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05050962013520050509620135205050962013520

GMDN Terms

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

Contacts

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

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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
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05050962011670SMALL TILTRITE MANUAL STANDARD BACKSTMST2024-02-02
05050962011687SMALL TILTRITE MANUAL SYMMETRIFORM BACKSTMSY2024-02-02
05050962023048LEG-UPLEG-UP BLACK 26INHA09702024-02-02
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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
05050962110168REACHERCLASSIC 32INHA61322024-02-02

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