FDA.reportPublic FDA data

NA

Primary DI
00817492021297
Brand
NA
Company
MAR COR PURIFICATION, INC.
Model
GENERATOR,O3Z,2.3GM/H
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIIDisinfectant, Dialysate Delivery System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIIDisinfectant, Dialysate Delivery SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492021297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492021297008174920212978174920212970817492021297

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8006333080info@mcpur.com

Regulatory Flags#

DUNS number
019056181
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492021815NAGENERATOR,O3Z-E,0-4GM/HRNA2017-04-06
00817492020979MCB SeriesMCB 205-50 MF BICARB SEMI SYS2016-09-23
00817492020986MCB SeriesMCB 205-100 MF BICARB SEMI SYS2016-09-23
00817492020993MCB SeriesMCB 212-50 BICARB SEMI SYS2016-09-23
00817492021006MCB SeriesMCB 212-100 BICARB SEMI SYS2016-09-23
00817492021013MCB SeriesMCB 202-50 BICARB SNGL SYS2016-09-23
00817492021020MCB SeriesMCB 202-100 BICARB SNGL SYS2016-09-23
00817492021037MCB SeriesMIXER,BICARB,MCB202-50CD,SINGLE,50GAL2016-09-23
00817492021044MCB SeriesMCB 202-100 CD BICARB SNGL SYS2016-09-23
00817492021051PSDS Bicarb SystemsPSDS,BICARB ONLY2016-09-23
00817492021068PSDS Bicarb SystemsPSDS,BICARB ONLY,HD2016-09-23
00817492021075PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB2016-09-23
00817492021082PSDS Bicarb SystemsPSDS,1 ACID,1 BICARB,HD2016-09-23
00817492021099PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB2016-09-23
00817492021105PSDS Bicarb SystemsPSDS,2 ACID,1 BICARB,HD2016-09-23
00817492021112PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB2016-09-23
00817492021129PSDS Bicarb SystemsPSDS,3 ACID,1 BICARB,HD2016-09-23
00817492021136SDS Bicarb SystemsSDS,REMOTE,BICARB ONLY,HD,70G TANK2016-09-23
00817492021143SDS Bicarb SystemsSDS,REMOTE,1 ACID,1 BICARB,HD,70G TANK2016-09-23
00817492021150SDS Bicarb SystemsSDS,REMOTE,2 ACID,1 BICARB,HD,70G TANK2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840861102723CitraSureFresenius Medical Care Renal Therapies Group, LLCNII2025-07-31
10840861102720CitraSureFresenius Medical Care Renal Therapies Group, LLCNII2025-07-31
00840861102396CitraSure™Fresenius Medical Care Renal Therapies Group, LLCNII2024-04-04
10840861102393CitraSure™Fresenius Medical Care Renal Therapies Group, LLCNII2024-04-04
00817492021815NAMAR COR PURIFICATION, INC.NII2017-04-06