AccessGUDID - DEVICE: PILLOW, QUEEN, SLING, MODULAR TABLE (00842430100352)

GUDID

Device Identifier (DI) Information

Brand Name: PILLOW, QUEEN, SLING, MODULAR TABLE
Version or Model: 6947
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6947
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430100352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: Made with Tempur-Pedic® Medical materials.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
15593	Bed pillow, reusable	A sealed fabric case (e.g., cotton, pure wool) stuffed with soft material (e.g., down, polyester, foam, buckwheat husks) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase and is laundered for cleaning between periods of use. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites; it is not dedicated to specialized applications/therapies. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	Support, Patient Position

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
Storage Environment Temperature: between 0 and 38 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46a9879f-f7de-4ebc-a08e-9ed881ee8159
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: May 31, 2017