NA

Basic Information

• Brand Name: NA
• Primary DI: 00852073002937
• Version / Model: Shapeable IUI Catheter, 15cm
• Catalog Number: TMI1193
• Company Name: C R I
• Labeler DUNS: 130814890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 3
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: d1119fbd-aaea-4d73-aa34-0449d8da0f4a

Device Description

Intrauterine Insemination Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	884.6110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45846	Assisted reproduction transfer catheter/set	A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10852073002934	GS1	Box	25	In Commercial Distribution
Primary	00852073002937	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5	French
Length	15	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry