FDA.reportPublic FDA data

MassTrak

Primary DI
00816776020292
Brand
MassTrak
Company
WATERS TECHNOLOGIES CORPORATION
Model
186002695IVD
Catalog number
186002695IVD
Device description
MassTrak TDM C18 2.1x10mm Column, IVD
Published
2022-02-15
Public version status
New
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
00816776020292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020292008167760202928167760202920816776020292

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser column IVDA component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Manufacturing date on label
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
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
00816776020018MassTrak™WATERS TECHNOLOGIES CORPORATIONDPM2016-09-24