AccessGUDID - DEVICE: Woddle (00860012873609)

GUDID

Device Identifier (DI) Information

Brand Name: Woddle
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C0401
Company Name: Woddle Baby, Inc.

Primary DI Number: 00860012873609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119198244 *Terms of Use

Device Description: Woddle Smart Changing Pad combines a medical-grade scale on a sleek, easy-to-clean and comfortable changing pad with simple activity tracking of weight, diaper changes, sleep and feedings directly on the screen.

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?
35324	Infant scale, electronic	An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as 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: 4545da18-b313-453d-b093-0f8ba3057f61
Public Version Date: June 10, 2025
Public Version Number: 1
DI Record Publish Date: June 02, 2025