FDA.reportPublic FDA data

MassTrak™

Primary DI
00816776020018
Brand
MassTrak™
Company
WATERS TECHNOLOGIES CORPORATION
Model
186002695
Catalog number
186002695
Device description
MassTrak™ TDM C18 2.1x10mm Column
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPMColumns, Liquid Chromatography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPMColumns, Liquid ChromatographyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816776020018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020018008167760200188167760200180816776020018

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser detector IVDA component of a high performance liquid chromatograph (HPLC) analyser designed to identify/quantify the chemical constituents of a liquid mixture of chemical compounds by electronically registering their rate of exit at the end of the analyser's column(s). Results are displayed graphically. Some analysers are connected to a mass spectrometer which acts as the detector.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius23 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-252-4752Customerservice@waters.com

Regulatory Flags#

DUNS number
107186004
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816776020551MassTrak186010565IVD186010564IVD2023-12-05
00816776020247MassTrak186010560IVD186010560IVD2022-12-22
00816776020544MassTrak186010563IVD186010563IVD2023-12-05
00816776020568MassTrak186010565IVD186010565IVD2023-12-05
00816776020575MassTrak186010566IVD186010566IVD2023-12-05
00816776020582MassTrak186010568IVD186010568IVD2023-12-05
00816776020599MassTrak186010567IVD186010567IVD2023-12-05
00816776020254Xevo186009782IVD186009782IVD2023-04-06
00816776020421MassTrak186009311IVD186009311IVD2021-10-25
00816776020438MassTrak186009312IVD186009312IVD2021-10-25
00816776020445Acquity186015082IVD186015082IVD2022-03-01
00816776020452Acquity186015088IVD186015088IVD2022-03-01
00816776020469Acquity186015087IVD186015087IVD2022-03-01
00816776020476Acquity186015014IVD186015014IVD2022-03-01
00816776020315Acquity725000662IVD725000662IVD2021-10-06
00816776020346Xevo186008453IVD186008453IVD2021-10-06
00816776020179Xevo186007833IVD186007833IVD2021-10-05
00816776020087Acquity186015007IVD186015007IVD2021-10-04
00816776020094Acquity186015010IVD186015010IVD2021-10-04
00816776020100Acquity186015020IVD186015020IVD2021-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336228630HPLC Cartridge (iHPLC)Roche Diagnostics GmbHDPM2025-07-31
07613336228647Rapid Cartridge B (iRapidB)Roche Diagnostics GmbHDPM2025-07-31
07613336228654Rapid Cartridge C (iRapidC)Roche Diagnostics GmbHDPM2025-07-31
00816776020292MassTrakWATERS TECHNOLOGIES CORPORATIONDPM2022-02-15
00816776020193AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020209AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020216AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020223AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020186AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-05