FDA.reportPublic FDA data

Hy-GeneTM Seminal Fluid Collection Kit

Primary DI
00862242000312
Brand
Hy-GeneTM Seminal Fluid Collection Kit
Company
APEX MEDICAL TECHNOLOGIES, INC.
Model
ACK-121
Catalog number
ACK-121
Device description
Specimen Collection Container for the collection of semen.
Published
2024-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00862242000312PackageGS130In Commercial Distribution
00862242000329PackageGS1100In Commercial Distribution
00862242000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862242000312008622420003128622420003120862242000312
00862242000329008622420003298622420003290862242000329
00862242000305008622420003058622420003050862242000305

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
154115885
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
00862242000305Hy-GeneTM Seminal Fluid Collection KitACK-121ACK-1212024-09-05
00862242000367EndosacTMES-1ES-12024-09-05
10862242000364EndosacTMES-1ES-12024-09-05
00862242000336Male-FactorPakTMMFP-130MFP-1302024-09-05

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