MOBICATH™

Basic Information

• Brand Name: MOBICATH™
• Primary DI: 00821329401008
• Version / Model: D140011
• Catalog Number: D140011
• Company Name: Greatbatch Ltd
• Labeler DUNS: 968623467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-06
• Public Version: 6
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: 2487dcf4-e104-41a7-84fb-308606a45a12

Device Description

MOBICATH™ Bi-Directional Guiding Sheath, Large Curve

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10821329401005	GS1		1	In Commercial Distribution
Primary	00821329401008	GS1

Device Sizes

Type	Value	Unit	Text
Length	180	Centimeter
Length	93.5	Centimeter
Length	91.8	Centimeter
Lumen/Inner Diameter	2.8	Millimeter
Length	72	Centimeter
Length	3.81	Centimeter
Angle	150	degree

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 40 Degrees Celsius