PARATherm

GUDID 00861047000329

bath, paraffin

GRIMM SCIENTIFIC INDUSTRIES INC

Physical therapy paraffin wax bath

• Primary Device ID: 00861047000329
• NIH Device Record Key: 19fcec57-910b-426b-8eee-231da564bc07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARATherm
• Version Model Number: PARATherm
• Company DUNS: 107330599
• Company Name: GRIMM SCIENTIFIC INDUSTRIES INC
• 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: 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: true

Customer Support Contacts

• Phone: 740.374.3412
• Email: glenn@grimmscientific.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861047000329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K842423

FDA Product Code

• IMC: Bath, Paraffin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-14

Devices Manufactured by GRIMM SCIENTIFIC INDUSTRIES INC

• 00861047000312 - CRYOPress: 2018-07-06 massager, powered inflatable tube
• 00861047000329 - PARATherm: 2018-07-06bath, paraffin
• 00861047000329 - PARATherm: 2018-07-06 bath, paraffin
• 00861047000305 - CRYOTherm: 2018-03-29 Immersion hydrobath.