AccessGUDID - DEVICE: Monarch (10688503201109)

GUDID

Device Identifier (DI) Information

Brand Name: Monarch
Version or Model: M929201-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Patient lifter
Company Name: Savaria Concord Lifts Inc

Primary DI Number: 10688503201109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245449095 *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):	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?
38129	Overhead track patient lifting/transfer system	A electrically-powered assembly of devices designed to enable an incapacitated patient or a person with a disability to be lifted/moved (transferred) safely and with minimal physical effort within the confines of one floor of a building, typically an institution or the person's home. It typically consists of ceiling-mounted track, and a motorized hoist and patient holding device (e.g., a sling, holder or a frame) for lifting and lowering the patient, that can be moved along the overhead track.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-Powered

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: 1478c6c3-dc2e-4d09-818b-ddcc3756a1a0
Public Version Date: January 24, 2024
Public Version Number: 1
DI Record Publish Date: January 16, 2024

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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