FDA.report

Woddle

Primary DI
00860012873609
Brand
Woddle
Company
Woddle Baby, Inc.
Model
1
Catalog number
C0401
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.
Published
2025-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FRWScale, Patient

Product Code Classifications

CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860012873609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012873609008600128736098600128736090860012873609

GMDN Terms

TermDefinition
Infant scale, electronicAn 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.

Sterilization Methods

Method

Contacts

PhoneEmail
(415) 459-7595support@woddlebaby.com

Regulatory Flags

DUNS number
119198244
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

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00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28
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00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16
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04012030021470seca 495seca GmbH & Co. KGFRW2024-05-01
04012030021487seca 495 rseca GmbH & Co. KGFRW2024-05-01
04012030021494seca 496seca GmbH & Co. KGFRW2024-05-01
04012030021500seca 604seca GmbH & Co. KGFRW2024-05-01
04012030021593seca 404seca GmbH & Co. KGFRW2024-05-01
04012030021609seca 446seca GmbH & Co. KGFRW2024-05-01
04012030021616seca 448seca GmbH & Co. KGFRW2024-05-01
04012030021623seca 476seca GmbH & Co. KGFRW2024-05-01
04012030021630seca 405seca GmbH & Co. KGFRW2024-05-01
04012030021647seca 438seca GmbH & Co. KGFRW2024-05-01
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04719846014893CharderCHARDER ELECTRONIC CO., LTD.FRW2024-04-17
00817517026917HopkinsMARKETLAB INC.FRW2023-09-08
04719846013766CharderCHARDER ELECTRONIC CO., LTD.FRW2023-04-13