Pintler Patient Warming System PPWS001

GUDID B389PPWS0011

The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low

PINTLER MEDICAL, LLC

Electric pad whole-body heating system pad Electric pad whole-body heating system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad External electric-heating core temperature regulation system pad

• Primary Device ID: B389PPWS0011
• NIH Device Record Key: d0f276c3-02a1-41c6-98ef-a57775686c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pintler Patient Warming System
• Version Model Number: PPWS001
• Catalog Number: PPWS001
• Company DUNS: 071459661
• Company Name: PINTLER MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx
• Phone: 18776209868
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B389PPWS0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113705

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-11