ambIT 220418

GUDID 20857595005026

Introducer- 8 inch

SUMMIT MEDICAL PRODUCTS, INC.

Subcutaneous tunneller, single-use

• Primary Device ID: 20857595005026
• NIH Device Record Key: 97ce1eec-abbd-4fb4-9431-86770f6b41b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ambIT
• Version Model Number: 220418
• Catalog Number: 220418
• Company DUNS: 831704841
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com
• Phone: (801) 352-1888
• Email: service@ambitpump.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857595005022 [Primary]
GS1	20857595005026 [Package]; Contains: 00857595005022; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• BSO: Catheter, Conduction, Anesthetic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-09

On-Brand Devices [ambIT]

• 20857595005873: Cassette - Filter, Spike
• 00857595005824: PIB*IL
• 00857595005817: PreSet PCA Pump - Green
• 20857595005729: Cassette - Filter, Male Neuraxial Connector
• 00857595005695: Yellow PIB*PCA Pump
• 00857595005688: PIB*PCA Pump
• 00857595005671: PCA Military Pump
• 00857595005664: RA PreSet Pump
• 00857595005640: St. Luke's PreSet Pump
• 00857595005626: PCRA Pump
• 00857595005619: UMROI Pump
• 00857595005602: PreSet Pump
• 00857595005596: PreSet Pump
• 00857595005589: PCA Pump
• 00857595005572: Continuous Pump
• 20857595005552: Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector
• 20857595005545: Cassette - Filter, Spike, and Neuraxial Connector
• 20857595005354: RA PreSet Pain Control System
• 20857595005347: Pain Control System - 3 inch Uni-Flo Fenestrated Catheter
• 20857595005330: Pain Control System - 10 inch Uni-Flo Fenestrated Catheter
• 20857595005323: Pain Control System - 5 inch Uni-Flo Fenestrated Catheter
• 20857595005316: Pain Control System - Basic with Filter Male Luer Cassette + MediBag
• 20857595005309: St. Luke's Pain Control System
• 20857595005286: Pain Control System - Basic with Filter Spike Cassette
• 20857595005279: UMROI Pain Control System
• 20857595005262: Pain Control System - Standard
• 20857595005255: Pain Control System - Basic
• 20857595005248: Pain Control System - Basic with Filterless Male Luer Cassette
• 00857595005213: Pain Control Kit - Standard
• 20857595005200: Pain Control Kit - Basic with Male Filter Cassette
• 20857595005194: Pain Control Kit - Basic with Filter Spike Cassette
• 20857595005187: Pain Control Kit - Basic with Shipper Cap
• 20857595005170: Pain Control Kit - Basic with 420 mL MediBag and Shipper Cap
• 20857595005163: Pain Control Kit - Basic with 420 ml Medibag
• 20857595005156: Pain Control Kit - Basic
• 20857595005149: Cassette Kit
• 20857595005132: Luer to Spike Adaptor
• 20857595005101: Cassette - Filter, Spike with Yellow Stripe Tubing
• 20857595005095: Cassette - Filterless, Male Luer
• 20857595005088: Cassette - Filter, Male Luer
• 20857595005071: Cassette - Filter, Male Luer
• 20857595005064: Cassette - Filter, Spike with Yellow Striped Tubing
• 20857595005057: Cassette - Filter, Spike with Blue Striped Tubing
• 20857595005040: Cassette - Filter, Spike
• 20857595005033: Cassette - Filterless, Spike
• 20857595005026: Introducer- 8 inch
• 20857595005996: ambIT System with Spike Filter Cassette
• 20857595005989: ambIT System with Male Filter Cassette
• 20857595005972: ambIT Kit with Spike Filter Cassette
• 20857595005965: ambIT Kit with Male Filter Cassette