AccessGUDID - DEVICE: SLEEP SYSTEM NITETIME (05050962257269)

GUDID

Device Identifier (DI) Information

Brand Name: SLEEP SYSTEM NITETIME
Version or Model: 'D' CUSHION
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA76
Company Name: THE HELPING HAND COMPANY (LEDBURY) LIMITED

Primary DI Number: 05050962257269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397307240 *Terms of Use

Device Description: SLEEP SYSTEM NITETIME

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63407	Assistive sleeping cushion set	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNJ	Bed, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f8d670e-e3cf-4270-bb99-c8487bbe284e
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024