FDA.reportPublic FDA data

Polyvinylpyrrolidone (PVP) - Lyophilized

Primary DI
00893727002989
Brand
Polyvinylpyrrolidone (PVP) - Lyophilized
Company
FUJIFILM IRVINE SCIENTIFIC, INC.
Model
99219-10x1mL
Catalog number
99219
Device description
PVP (polyvinylpyrrolidone)
Published
2016-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQLMedia, Reproductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991343000PVP (POLYVINYLPYRROLIDONE)Irvine Scientific Sales Co., Inc.1999-07-14MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893727002989PrimaryGS10
10893727002986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893727002989008937270029898937270029890893727002989
1089372700298610893727002986

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004375706tmrequest@irvinesci.com

Regulatory Flags#

DUNS number
057475246
Device count
10
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161790127CaseBio®CaseBioscience IncMQL2026-10-31
07540161790134CaseBio®CaseBioscience IncMQL2026-10-31
00888937028508LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028515LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028522LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028539LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028546LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028614LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028621LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028638LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028645LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028652LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028669LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028676LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028683LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028690LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028706LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028713LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028935LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028942LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029017LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029024LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029031LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029130LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029147LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029154LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029161LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029178LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029185LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03