ambIT

Basic Information

• Brand Name: ambIT
• Primary DI: 00850000509047
• Version / Model: 220573
• Catalog Number: 220573
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 831704841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-23
• Public Version: 1
• Public Version Date: 2020-05-01
• Public Version Status: New
• Public Device Record Key: cef00f1e-e787-4cf5-8629-d5f5398d067c

Device Description

PIB/PCA v1.5 Pain Control System-Basic

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	20850000509041	GS1		5	In Commercial Distribution
Primary	00850000509047	GS1

Customer Contacts

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