FDA.reportPublic FDA data

Water for Assisted Reproductive Technologies (A.R.T.) Use

Primary DI
00893727002880
Brand
Water for Assisted Reproductive Technologies (A.R.T.) Use
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
9307-1L
Catalog number
9307
Device description
Water for Assisted Reproductive Technologies (A.R.T.) Use
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

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
K011598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011598000WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USEIrvine Scientific Sales Co., Inc.2001-06-13MTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893727002880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893727002880008937270028808937270028800893727002880

GMDN Terms#

Term, Definition table
TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature away from light
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8004375706tmrequest@irvinesci.com

Regulatory Flags#

DUNS number
057475246
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893727002200Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-100mL901282016-09-10
00893727002361ISolate®99264-2x50mL992642016-09-10
00893727002903Human Serum Albumin Solution9988-100mL99882016-09-10
00893727002002Oil for Embryo Culture9305-100mL93052016-09-10
00893727002019PBS 1X - Dulbecco's Phosphate Buffered Saline Solution9235-500mL92352016-09-10
00893727002071Sperm Washing Medium9983-100mL99832016-09-10
00893727002088Sperm Washing Medium9983-12X12mL99832016-09-10
00893727002101Human Serum Albumin Solution9988-12X5mL99882016-09-10
00893727002125Hyaluronidase Solution90101-5X1mL901012016-09-10
008937270021637% PVP Solution with HSA90121-5X0.5mL901212016-09-10
0089372700217010% PVP Solution with HSA90123-5X0.5mL901232016-09-10
00893727002217Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin90128-20X5mL901282016-09-10
00893727002354ISolate®99264-12X6mL992642016-09-10
00893727002378ISolate® Concentrate99306-100ml993062016-09-10
00893727002781Oil for Embryo Culture9305-500mL93052016-09-10
00893727002859ISolate® Stock Solution99275-100ML992752016-09-10
00893727002194Modified HTF Medium-HEPES with Gentamicin90126-100mL901262016-09-10
00893727002804HTF Medium with Gentamicin90125-100mL901252016-09-10
00893727002910HTF Medium with Gentamicin90125-500mL901252016-09-10
00893727002927Modified HTF Medium-HEPES with Gentamicin90126-500mL901262016-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00805360018494Enhance Water for Tissue CultureVITROLIFE INC.MTW2018-04-23
00008053608495Enhance Water for Tissue CultureVITROLIFE INC.MTW2018-04-23
00857515006078Water for Assisted Reproductive Technologies (A.R.T.) UseFUJIFILM IRVINE SCIENTIFIC, INC.MTW2016-09-10