FDA.reportPublic FDA data

ProteX

Primary DI
B6861PC0010SRS010000
Brand
ProteX
Company
RSI Technology Group, LLC
Model
1
Catalog number
1PC0010SRS010000
Device description
A 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. Case of 10 units.
Published
2024-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6861PC0010SRS010000PrimaryHIBCC0
B68610001Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
8004650368Support@reproductive.solutions

Regulatory Flags#

DUNS number
118022050
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6861PLSS25SRS0100000ProteX Safe-Seal1600042023-08-23
B686200011ProteX1600022023-08-02
B686600050ProteX with FlightLock Technology1600052026-04-01
B686600061ProteX with FlightLock Technology1600062026-04-01
B6861PLSS01SRS0100000ProteX Safe-Seal1600032023-08-23
B686100010ProteX1100012023-03-29
B686100SB25SRS0300001NovoSort1800022023-08-23
B686100SB01SRS0300000NovoSort1800012023-08-23
B686100SB10SRS030000NovoSort1100SB10SRS0300002024-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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H108117041CorningCorning IncorporatedFMH2025-10-28
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10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
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10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
H1084316251CorningCorning IncorporatedFMH2024-10-29