FDA.reportPublic FDA data

Male-FactorPakTM

Primary DI
00862242000336
Brand
Male-FactorPakTM
Company
APEX MEDICAL TECHNOLOGIES, INC.
Model
MFP-130
Catalog number
MFP-130
Device description
Specimen Collection Container used to collect semen.
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HISCondom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HISCondomObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954791000SEMINAL FLUID COLLECTION KIT IIApex Medical Technologies, Inc.1996-01-05HIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862242000343PackageGS1100In Commercial Distribution
00862242000350PackageGS130In Commercial Distribution
00862242000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862242000343008622420003438622420003430862242000343
00862242000350008622420003508622420003500862242000350
00862242000336008622420003368622420003360862242000336

GMDN Terms#

Term, Definition table
TermDefinition
Semen specimen collection containerA sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius38 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
858-535-0012sales@apexfertility.com

Regulatory Flags#

DUNS number
154115885
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862242000305Hy-GeneTM Seminal Fluid Collection KitACK-121ACK-1212024-09-05
00862242000367EndosacTMES-1ES-12024-09-05
00862242000312Hy-GeneTM Seminal Fluid Collection KitACK-121ACK-1212024-09-05
10862242000364EndosacTMES-1ES-12024-09-05

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Primary DI, Brand, Company table
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