ambIT

Basic Information

• Brand Name: ambIT
• Primary DI: 00857595005343
• Version / Model: 220473
• Catalog Number: 220473
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 831704841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-05-22
• Public Version Status: Update
• Public Device Record Key: 50d5677d-e87d-458b-969d-a016a612a9bb

Device Description

Pain Control System - 3 inch Uni-Flo Fenestrated Catheter

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFQ	Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20857595005347	GS1		5	In Commercial Distribution
Primary	00857595005343	GS1

Customer Contacts

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