Centrisol Acid Concentrate

Primary DI
30677964000608
Brand
Centrisol Acid Concentrate
Company
MEDIVATORS INC.
Model
SB-151
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FKBConnector, Blood Tubing, Infusion T

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKBConnector, Blood Tubing, Infusion TGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K843963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843963000DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDRenal Systems, Inc.1985-01-07FKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30677964000608PackageGS14In Commercial Distribution
00677964000607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3067796400060830677964000608
00677964000607006779640006076779640006070677964000607

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis concentrateA product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964000607Centrisol Acid ConcentrateMEDIVATORS INC.FKB2016-09-20