Pintler Patient Warming System

Primary DI
B389PPWS0011
Brand
Pintler Patient Warming System
Company
PINTLER MEDICAL, LLC
Model
PPWS001
Catalog number
PPWS001
Device description
The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired
Published
2019-02-11
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
K113705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113705000PINTLER PATIENT WARMING SYSTEMPintler Medical2012-08-31DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B389PPWS0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating system padAn electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18776209868xx@xx.xx

Regulatory Flags#

DUNS number
071459661
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

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