107650

GUDID 37332414075829

SP 418 (9L Bag) Accessory Drain Bag

GAMBRO DASCO SPA

Extracorporeal circuit waste bag, sterile
Primary Device ID37332414075829
NIH Device Record Keyc28c6df6-bb6c-4928-ab9b-aff64e2385dd
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6033765
Catalog Number107650
Company DUNS428788780
Company NameGAMBRO DASCO SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
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

Device Dimensions

Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter
Total Volume9 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Minimum temperature of use 20 degree Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332414075828 [Primary]
GS137332414075829 [Package]
Contains: 07332414075828
Package: CASE [30 Units]
In Commercial Distribution

FDA Product Code

MONSYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30

Devices Manufactured by GAMBRO DASCO SPA

37332414075829 - NA2021-08-09SP 418 (9L Bag) Accessory Drain Bag
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 - NA2019-06-07 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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