CultureSafe

GUDID 10810050855256

Blood Culture Bottle Dispensing Device

TYPENEX MEDICAL LLC

Blood/blood culture specimen transfer spike IVD
Primary Device ID10810050855256
NIH Device Record Keyc7b263f8-e972-4737-aa75-76fce374fbde
Commercial Distribution StatusIn Commercial Distribution
Brand NameCultureSafe
Version Model NumberAW0101
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050855259 [Primary]
GS110810050855256 [Package]
Contains: 00810050855259
Package: Inner Case [60 Units]
In Commercial Distribution
GS120810050855253 [Package]
Package: Outer Case [360 Units]
In Commercial Distribution

FDA Product Code

LIBDevice, General Purpose, Microbiology, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

Devices Manufactured by TYPENEX MEDICAL LLC

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26941850890275 - Anesthesia Breathing Circuit Kit2024-05-16 Adult Anesthesia Breathing Circuit Kit - 90" Dual Limb Breathing Circuit - Bacterial Viral Filter - Size 5 Anesthesia Mask - 3L
00810050855488 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Blue
00810050855501 - Tourniquets2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Blue
00810050855525 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Orange
00810050855549 - Tourniquets2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Orange
00810050855563 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Flat, Blue
00810050855587 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Flat, Orange

Trademark Results [CultureSafe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CULTURESAFE
CULTURESAFE
97718878 not registered Live/Pending
Typenex Medical, LLC
2022-12-15

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