FDA.reportPublic FDA data

AC Power Adapter Subassembly Kit

Primary DI
00851446007098
Brand
AC Power Adapter Subassembly Kit
Company
VITA HEAT MEDICAL
Model
1000026-PA-SA
Device description
The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter as a subassembly. This includes Model 100026-PA, but is packaged seperately from a system configuration.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132454000VITAHEAT PATIENT WARMING SYSTEMVitaheat Medical, LLC2013-10-04DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851446007098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851446007098008514460070988514460070980851446007098

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supplyA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.850.8350pfarmakis@vitaheatmedical.com

Regulatory Flags#

DUNS number
021249224
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851446007104VitaHEAT UB3 Patient Warming System - Battery Power7003-A2016-09-23
00851446007128VitaHEAT UB3 Patient Warming System - AC Power7003-B2016-09-23
00851446007142VitaHEAT UB3 Patient Warming System- Battery and AC Power7003-C2016-09-23
00851446007005Patient Warming Mattress40032016-09-23
00851446007012Controller20022016-09-23
00851446007067AC Power Adapter 100026-PA2016-09-23
00851446007043Battery Charger3001-C2016-09-23
00851446007081Battery Power Subassembly3001262016-09-23
00851446007036Battery1000262016-09-23

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Primary DI, Brand, Company table
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