ProCure™ PC1301

GUDID 30840330703612

Hot Pack- Hot Pack Instant 6"x 9" - 24ea/cs

Twin Med, LLC

Hot/cold therapy pack, single-use

• Primary Device ID: 30840330703612
• NIH Device Record Key: 6fbb6c77-96ac-43f5-bd0f-492c9fc26fc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCure™
• Version Model Number: PC1301
• Catalog Number: PC1301
• Company DUNS: 107071289
• Company Name: Twin Med, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com

Device Dimensions

• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch
• Width: 6 Inch
• Length: 9 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Freezing & Direct Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840330703618 [Primary]
GS1	30840330703612 [Package]; Contains: 10840330703618; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• IMD: Pack, Hot Or Cold, Disposable

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: 2023-10-12
• Device Publish Date: 2023-10-04

On-Brand Devices [ProCure™]

• 30840330703681: ProCure Safe Insulin Safety Syringe 1/2cc 31g x 5/16" 100ea/bx 8bx/cs
• 30840330703674: ProCure Safe Insulin Safety Syringe 1cc 31g x 5/16" 100ea/bx 8bx/cs
• 30840330703667: ProCure Safe TB Tuberculin Safety Syringe 1ml 28g x 1/2" - 100ea/bx 8bx/cs
• 30840330703650: ProCure Safe TB Tuberculin Safety Syringe 1ml 27g x 1/2" - 100ea/bx 8bx/cs
• 30840330703643: ProCure Safe TB Tuberculin Safety Syringe 1ml 25g x 5/8" - 100ea/bx 8bx/cs
• 30840330703636: ProCure™ Safe Insulin Safety Syringe 1/2cc 29g x 1/2" 100ea/bx 8bx/cs
• 30840330703629: ProCureSafe Insulin Safety Syringe 1cc 29g x 1/2" 100ea/bx 8bx/cs
• 30840330703612: Hot Pack- Hot Pack Instant 6"x 9" - 24ea/cs
• 30840330703605: Cold Pack- Ice Pack Instant 6"x 9" - 24ea/cs