ambIT 220546

GUDID 00850000509023

PIB*PCA v1.5 Pump

SUMMIT MEDICAL PRODUCTS, INC.

General-purpose infusion pump, battery-powered Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electric Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic Ambulatory non-insulin infusion pump, electronic

• Primary Device ID: 00850000509023
• NIH Device Record Key: cdb98885-6b0a-4b5c-8a56-4685aa6a5338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ambIT
• Version Model Number: 220546
• Catalog Number: 220546
• Company DUNS: 831704841
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: (801)352-1888
• Email: service@ambitpump.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000509023 [Primary]

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

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• 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
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• 20857595005316: Pain Control System - Basic with Filter Male Luer Cassette + MediBag
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• 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