FDA.reportPublic FDA data

CaseBioscience®

Primary DI
07540161790042
Brand
CaseBioscience®
Company
CaseBioscience Inc
Model
APBS-500
Catalog number
APBS-500
Device description
CaseBioscience® PBS1X-Dulbecco's Phosphate Buffered Saline Solution 500 mL
Published
2024-01-31
Public version status
New
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
QKIMedia, Reproductive, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKIMedia, Reproductive, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540161790042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161790042075401617900427540161790042

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 Volume500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from sunlight and radioactive sources.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(226) 243-6483sales@casebioscience.com

Regulatory Flags#

DUNS number
209069774
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540161790059CaseBioscience®CMON-050CMON-0502025-10-30
07540161790066CaseBioscience®WHMO-100WHMO-1002025-10-30
07540161790073CaseBioscience®HTFC-100HTFC-1002025-10-30
07540161790080CaseBioscience®HHTF-100HHTF-1002025-10-30
07540161790028CaseBioscience®VSOL-100VSOL-1002024-01-31
07540161790035CaseBioscience®MNOL-100MNOL-1002024-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161790028CaseBioscience®CaseBioscience IncQKI2024-01-31
07540161790035CaseBioscience®CaseBioscience IncQKI2024-01-31
05745000591022ARTSMedia High Viscosity Oil (AM-HV Oil)Artsmedia Denmark ApSQKI2024-01-22
05745000591039ARTSMedia High Viscosity Oil (AM-HV Oil)Artsmedia Denmark ApSQKI2024-01-22
04582231461639Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231461646Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231461653Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231461660Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467198Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467204Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467211Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467228Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467235Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467242Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467259Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467266Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
05411967000470FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967000487FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967000500FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001170FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001194FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001217FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001231FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001248FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001255FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001187FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001200FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001224FertiCult High Viscosity OilFertipro NVQKI2023-02-28
06971982050397VitaVitroSHENZHEN VITAVITRO BIOTECH CO.,LTD.QKI2022-12-22
06971982050403VitaVitroSHENZHEN VITAVITRO BIOTECH CO.,LTD.QKI2022-12-22