FDA.reportPublic FDA data

Enhance Water for Tissue Culture

Primary DI
00008053608495
Brand
Enhance Water for Tissue Culture
Company
VITROLIFE INC.
Model
15522
Device description
Enhance Water for Tissue Culture, 1.5 Liter
Published
2018-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MTWSystem, Water, Reproduction, Assisted, And Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTWSystem, Water, Reproduction, Assisted, And PurificationObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993140000WATER FOR TISSUE CULTURE, MODELS 1500Conception Technologies2000-08-02MTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00008053608495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00008053608495000080536084950080536084950008053608495

GMDN Terms#

Term, Definition table
TermDefinition
Sterile solution storage bottle, single-useAn empty glass or plastic container, typically with a relatively narrow neck, intended for the safe storage and easy handling of sterile solutions (e.g., sterile distilled water or saline) that are used during intravenous and/or irrigation procedures. It is produced in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051915038
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
false
Expiration date on label
true
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
00805360016865Enhance Sperm Wash w/ Gentamicin152632018-04-20
00805360018494Enhance Water for Tissue Culture155222018-04-23
00805360014106Handling Pipette155302021-09-03
00805360014113Handling Pipette155312021-09-03
00805360014120Handling Pipette155322021-09-03
00805360014144Handling Pipette155332021-09-03
00805360014151Handling Pipette155342021-09-03
00805360014168Handling Pipette155352021-09-03
00805360014175Handling Pipette155362021-09-03
00805360014182Handling Pipette155372021-09-03
00805360014199Handling Pipette155382021-09-03
10805360014103Handling Pipette155302021-09-03
10805360014110Handling Pipette155312021-09-03
10805360014127Handling Pipette155322021-09-03
10805360014141Handling Pipette155332021-09-03
10805360014158Handling Pipette155342021-09-03
10805360014165Handling Pipette155352021-09-03
10805360014172Handling Pipette155362021-09-03
10805360014189Handling Pipette155372021-09-03
10805360014196Handling Pipette155382021-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00805360018494Enhance Water for Tissue CultureVITROLIFE INC.MTW2018-04-23
00893727002880Water for Assisted Reproductive Technologies (A.R.T.) UseFUJIFILM IRVINE SCIENTIFIC, INC.MTW2016-09-10
00857515006078Water for Assisted Reproductive Technologies (A.R.T.) UseFUJIFILM IRVINE SCIENTIFIC, INC.MTW2016-09-10