Recirculation Adapter/Priming Connector 106283

GUDID 37332414055180

This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.

Gambro Renal Products, S.A. de C.V.

Haemodialysis blood tubing set, single-use
Primary Device ID37332414055180
NIH Device Record Keyd1105f7a-c208-408f-8107-19e51ce4d1e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRecirculation Adapter/Priming Connector
Version Model Number106283
Catalog Number106283
Company DUNS812560399
Company NameGambro Renal Products, S.A. de C.V.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com
Phone+1(800)933-0303
EmailMedinfo_medproducts@baxter.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place
Storage Environment TemperatureBetween -18 Degrees Celsius and 49 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *The accessory system must be stored in a dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414055189 [Primary]
GS137332414055180 [Package]
Contains: 07332414055189
Package: CASE [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2015-10-23

Devices Manufactured by Gambro Renal Products, S.A. de C.V.

37332414007813 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414007837 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414007868 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414007882 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414046836 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414055180 - Recirculation Adapter/Priming Connector2019-06-07This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.
37332414055180 - Recirculation Adapter/Priming Connector2019-06-07 This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation
37332414085217 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System
37332414112395 - Cartridge Blood Set2019-06-07 The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System

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