AP240-01 MICROBORE WITH NON-VENTED SPIKE,1.2 FILTER AND BACK CHECK VALVE 12003-000-0069

GUDID 27290109159274

Q-CORE MEDICAL LTD

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

Primary Device ID	27290109159274
NIH Device Record Key	12b559e8-136e-4390-b3f9-633e6683f10e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AP240-01 MICROBORE WITH NON-VENTED SPIKE,1.2 FILTER AND BACK CHECK VALVE
Version Model Number	12003-000-0069
Catalog Number	12003-000-0069
Company DUNS	533108028
Company Name	Q-CORE MEDICAL LTD
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	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com
Phone	949.288.5480
Email	Customerrservicena@eitangroup.com

Operating and Storage Conditions

Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290109159277 [Primary]
GS1	27290109159274 [Package] Contains: 17290109159277 Package: Cardboardbox [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123049

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-25
Device Publish Date	2019-06-17

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