AccessGUDID - DEVICE: EasyStand (10858921006031)

GUDID

Device Identifier (DI) Information

Brand Name: EasyStand
Version or Model: Evolv Large Glider
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALTIMATE MEDICAL INC.

Primary DI Number: 10858921006031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148515216 *Terms of Use

Device Description: No description.

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):	Yes
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?
61704	Manual stander/exerciser	A manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.	Active	false
61703	Electric stander/exerciser	An electrically-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement) and an electrically-powered lifting mechanism to raise the patient from a supine and/or seated position to standing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INO	Chair, Positioning, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062402	000

Device Exempt from Premarket Submission: No 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: 890ea61d-ab89-4ac0-bdf2-c30121f52154
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 19, 2016

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

[?]

No Customer Contact currently defined

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