AccessGUDID - DEVICE: Health o meter Professional (00892076002183)

GUDID

Device Identifier (DI) Information

Brand Name: Health o meter Professional
Version or Model: 1524KL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pelstar, LLC

Primary DI Number: 00892076002183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037289290 *Terms of Use

Device Description: Pediatric Beam Scale with Tray

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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36817	Infant scale, mechanical	A mechanical device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes during critical care procedures. It typically consists of a weight tray, a beam lever system mounted on a hardened steel pivot point, and a sliding weight(s) that can be moved along the weight scale to indicate the occupant's weight when it is in balance. The device is also known as a paediatric or baby scale.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRW	Scale, Patient

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: 780278b8-975c-410b-8d4a-fcb49d30b69c
Public Version Date: January 18, 2022
Public Version Number: 1
DI Record Publish Date: January 10, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

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

Secondary DI

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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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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