101354

GUDID 37332414004690

S-660-C Accessory Y connector

GAMBRO DASCO SPA

Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use
Primary Device ID37332414004690
NIH Device Record Keyfdaade90-24b9-4f0a-9f1f-316058f22795
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6431233B
Catalog Number101354
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Must be stored in a dry place. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use: 20 degrees celsius or 68 degrees fahrenheit
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414004699 [Primary]
GS137332414004690 [Package]
Contains: 07332414004699
Package: CASE [50 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 Date2016-10-28

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37332414044733 - NA2019-06-07 SP-390 Accessory adaptor
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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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