105762

GUDID 37332414048915

GMB-SP127 Accessory Y connector

GAMBRO DASCO SPA

Haemodialysis blood tubing set, single-use
Primary Device ID37332414048915
NIH Device Record Key54f21eed-a136-473a-b988-7be328cbe5ee
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6432470A
Catalog Number105762
Company DUNS428788780
Company NameGAMBRO DASCO SPA
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 Datetrue
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
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
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
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 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place
Special Storage Condition, SpecifyBetween 0 and 0 *The accessories for hemodialysis must be stored in a dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414048914 [Primary]
GS137332414048915 [Package]
Contains: 07332414048914
Package: CASE [25 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 Date2016-05-06

Devices Manufactured by GAMBRO DASCO SPA

37332414075829 - NA2021-08-09 SP 418 (9L Bag) Accessory Drain Bag
37332414004690 - NA2019-06-07 S-660-C Accessory Y connector
37332414010868 - NA2019-06-07 SP-C13 Accessory spike
37332414032532 - NA2019-06-07 SP-394 Accessory reinfusion line
37332414044733 - NA2019-06-07 SP-390 Accessory adaptor
37332414048915 - NA2019-06-07GMB-SP127 Accessory Y connector
37332414048915 - NA2019-06-07 GMB-SP127 Accessory Y connector
37332414075430 - NA2019-06-07 SP-420 Accessory extension line
07332414106119 - EXALIS2018-12-17 Exalis is an integrated product able to acquire, process and supply data required when running a dialysis treatment. This softwa

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