AccessGUDID - DEVICE: Care Continuum Chair (00850043655008)

GUDID

Device Identifier (DI) Information

Brand Name: Care Continuum Chair
Version or Model: CCC-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tpm Research, Inc.

Primary DI Number: 00850043655008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098690655 *Terms of Use

Device Description: The TPM Research model CCC-1000 Care Continuum Chair is a manual operator-propelled chair that is designed for transport and use of seated occupants with their associated medical equipment (including oxygen bottle or IV fluid bags). The product is equipped with an electronic positioning system that assists with occupant entry and exit.

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?
66678	Stand-assistive attendant-only-propelled wheelchair	An electrically-powered device designed to be used by a healthcare provider for: 1) manual (non-electric) transport of a non-bariatric patient with a disability, or without the full capacity to walk, in a seated position over a short distance (indoors or over smooth paved surfaces); and 2) electronically-assisted patient standing. It is designed as a wheelchair with small caster wheels (inadequate for occupant self-propulsion) and a seat-lifting/footrest-lowering electronic stand-assistive mechanism; it cannot be folded or readily dismantled for transport. It is typically used in hospitals and institutions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INO	Chair, Positioning, Electric

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
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e30d358a-ee9f-44a6-80d6-ccb85bb5ad25
Public Version Date: April 14, 2023
Public Version Number: 1
DI Record Publish Date: April 06, 2023