FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRWScale, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012873609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012873609008600128736098600128736090860012873609

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
(415) 459-7595support@woddlebaby.com

Regulatory Flags#

DUNS number
119198244
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030022927seca 406seca GmbH & Co. KGFRW2026-04-22
H933P11634Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FRW2025-12-03
04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
04719846016040CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
40080196291237MEDLINEMEDLINE INDUSTRIES, INC.FRW2025-06-25
10688503001051SavariaSavaria Concord LiftFRW2025-05-29
10688503001068SavariaSavaria Concord LiftFRW2025-05-29
00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28
00628725008271SMART SCALECanadian Hospital Specialties LimitedFRW2025-02-28
00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16
04012030003711seca 206seca GmbH & Co. KGFRW2024-10-01
04012030003759seca 212seca GmbH & Co. KGFRW2024-10-01
04012030004381seca 206seca GmbH & Co. KGFRW2024-10-01
04012030007252seca 201seca GmbH & Co. KGFRW2024-10-01
04012030007269seca 201seca GmbH & Co. KGFRW2024-10-01
14012030003718seca 206seca GmbH & Co. KGFRW2024-10-01
14012030003756seca 212seca GmbH & Co. KGFRW2024-10-01
24012030004385seca 206seca GmbH & Co. KGFRW2024-10-01
14012030007259seca 201seca GmbH & Co. KGFRW2024-10-01
24012030007263seca 201seca GmbH & Co. KGFRW2024-10-01
05600494138736WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUSINVACARE CORPORATIONFRW2024-08-15
00732094251050Welch Allyn, Inc.WELCH ALLYN, INC.FRW2024-08-14
04012030021081seca 442seca GmbH & Co. KGFRW2024-05-07
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