Epimed International, Inc.

GUDID 00818788022295

PainBlocker Console (CO²), Foot and Cart

EPIMED INTERNATIONAL, INC

Cryogenic analgesia unit

• Primary Device ID: 00818788022295
• NIH Device Record Key: 0093ddc7-8f94-4b7b-8860-a48afb02917d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epimed International, Inc.
• Version Model Number: 401-PBSYS
• Company DUNS: 799751953
• Company Name: EPIMED INTERNATIONAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818788022295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854334

FDA Product Code

• GXH: DEVICE, SURGICAL, CRYOGENIC

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: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [Epimed International, Inc.]

• 10818788020410: RF™ Coudé® Blunt 20g TW x 10cm with 15mm Active Tip
• 10818788021431: RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip
• 10818788020540: Plastic L.O.R./ 18g x 3.5" Tuohy
• 10818788023695: Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemosta
• 10818788021509: Plastic L.O.R./ 22g x 3.5" Tuohy
• 10818788021486: Plastic L.O.R./ 20g x 3.5" Tuohy
• 00818788022295: PainBlocker Console (CO²), Foot and Cart