Respiratory Belt BPL002

GUDID 00841439102282

Respiratory Belt

MEDTEC, INC.

Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system Indexed-immobilization patient positioning system

• Primary Device ID: 00841439102282
• NIH Device Record Key: 0794c1ef-51cc-435b-860d-42b5587aa995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respiratory Belt
• Version Model Number: BPL002
• Catalog Number: BPL002
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch
• Length: 69 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153026

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-30
• Device Publish Date: 2017-08-02

On-Brand Devices [Respiratory Belt]

• 00841439107263: Respiratory Belt
• 00841439102282: Respiratory Belt