TMI1154

GUDID 00852073002548

Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based contrast media

C R I

Intrauterine imaging medium catheter

• Primary Device ID: 00852073002548
• NIH Device Record Key: ed797b71-4bec-4d43-b574-b666726c734d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5F HS Catheter
• Catalog Number: TMI1154
• Company DUNS: 130814890
• Company Name: C R I
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: (800) 556-0349
• Email: Sales@ThomasMedical.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852073002548 [Primary]
GS1	10852073002545 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032835

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-08

Devices Manufactured by C R I

• 10852073002361 - NA: 2020-07-02 Round Loop, Loop Size: 20mm x 13mm
• 10852073002378 - NA: 2020-07-02 Round Loop, Loop Size: 20mm x 15mm
• 10852073002316 - NA: 2020-06-29 Round Loop, Loop Size: 15mm x 15mm
• 10852073002484 - NA: 2020-06-29 Round Loop, Loop Size: 15mm x 10mm
• 00852073002814 - NA: 2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con
• 10852073002231 - NA: 2019-05-27 Square Loop, Loop Size: 10mm x 4mm
• 10852073002248 - NA: 2019-05-27 Round Loop, Loop Size: 5mm x 5mm
• 10852073002255 - NA: 2019-05-27 Round Loop, Loop Size: 10mm x 5mm