LAP-BAND System Access Port I Kit

Basic Information

• Brand Name: LAP-BAND System Access Port I Kit
• Primary DI: 10811955020107
• Version / Model: B-2104
• Catalog Number: B-2104
• Company Name: Apollo Endosurgery, Inc.
• Labeler DUNS: 625064352
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-26
• Public Version: 3
• Public Version Date: 2020-11-23
• Public Version Status: Update
• Public Device Record Key: 6d2ce587-7999-4b3d-b82f-7ea1376da1e0
• Distribution End Date: 2020-11-20

Device Description

Access Port I Kit 0-10CC

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
LTI	Implant, Intragastric For Morbid Obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47065	Gastric band access port kit	A collection of sterile devices designed to establish a replacement access port for an implanted gastric band of the adjustable type that is invasively inflated. It typically includes access port needles, an access port, an end plug, a connector, and tubing to connect the new port to the existing gastric band. It is typically used when the original port must be removed due to leaks, infection, or contamination. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811955020107	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0-10 cc