AP402-01 MICROBORE EPIDURAL YELLOW MARKED WITH VENTD_NON-VENTED SPIKE 12004-000-0004

GUDID 27290109153142

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 Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use
Primary Device ID27290109153142
NIH Device Record Keyd152819d-0cab-4e25-8b5c-e3002b8034da
Commercial Distribution StatusIn Commercial Distribution
Brand NameAP402-01 MICROBORE EPIDURAL YELLOW MARKED WITH VENTD_NON-VENTED SPIKE
Version Model Number12004-000-0004
Catalog Number12004-000-0004
Company DUNS533108028
Company NameQ-CORE MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com
Phone949.288.5482
Emailcustomerservice@eitanmedical.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS117290109154548 [Primary]
GS127290109153142 [Package]
Contains: 17290109154548
Package: Cardboard box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-15

Devices Manufactured by Q-CORE MEDICAL LTD

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17290109153985 - Infusion Pouch 500mL2022-11-14
17290109154043 - Homecare Large Backpack2022-11-14
17290109154050 - Communication Cable -US 2022-11-14
27290109153937 - Multi-Pump Bracket Kit - US (4 units)2022-11-14
27290109154071 - Multi-Pump Mounting System compatible with IPS- A2022-05-24
17290109153046 - AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE2022-05-23
27290109153067 - AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA2022-05-23
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