ACID CONCENTRATE 5M8005A

GUDID 50085412150616

Concentrated Hemodialysis Solution

BAXTER INTERNATIONAL INC.

Haemodialysis concentrate
Primary Device ID50085412150616
NIH Device Record Key0dca578d-f9ca-42c7-9833-4b6fa99234dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameACID CONCENTRATE
Version Model Number5M8005A
Catalog Number5M8005A
Company DUNS005146311
Company NameBAXTER INTERNATIONAL INC.
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

Device Dimensions

Total Volume4.5 Liter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Avoid freezing.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Avoid freezing.

Device Identifiers

Device Issuing AgencyDevice ID
GS100085412150611 [Primary]
GS150085412150616 [Package]
Contains: 00085412150611
Package: CASE [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPODIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [ACID CONCENTRATE]

50085412150623Concentrated Hemodialysis Solution
50085412150616Concentrated Hemodialysis Solution
50085412150593Concentrated Hemodialysis Solution
50085412150586Concentrated Hemodialysis Solution
50085412150579Concentrated Hemodialysis Solution
50085412150562Concentrated Hemodialysis Solution

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