AccessGUDID - DEVICE: Lumex (M368FR587W92011)

GUDID

Device Identifier (DI) Information

Brand Name: Lumex
Version or Model: FR587W9201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FR587W9201
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M368FR587W92011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: RECL X WD CL CARE COBBLESTONE

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):	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?
36985	Reclining chair	A manually-operated, general-purpose device designed to support a patient in a seated position; it includes a back rest that reclines for patient comfort. The chair is intended to be used in a variety of settings including recovery from minor procedures, during convalescence, while donating blood, or while receiving chemotherapy. It may have a height-adjustable mechanism and have attached armrests, footrests, and/or legrests.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: df3602af-ab83-473b-96a7-f97f83e7b13e
Public Version Date: May 11, 2021
Public Version Number: 1
DI Record Publish Date: May 03, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 770-368-4700
Email: cs@grahamfield.com

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