CultureSafe
GUDID 10810050855256
Blood Culture Bottle Dispensing Device
TYPENEX MEDICAL LLC
Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD| Primary Device ID | 10810050855256 |
| NIH Device Record Key | c7b263f8-e972-4737-aa75-76fce374fbde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CultureSafe |
| Version Model Number | AW0101 |
| Company DUNS | 600850213 |
| Company Name | TYPENEX MEDICAL LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050855259 [Primary] |
| GS1 | 10810050855256 [Package] Contains: 00810050855259 Package: Inner Case [60 Units] In Commercial Distribution |
| GS1 | 20810050855253 [Package] Package: Outer Case [360 Units] In Commercial Distribution |
FDA Product Code
| LIB | Device, General Purpose, Microbiology, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
Devices Manufactured by TYPENEX MEDICAL LLC
| 00810050855488 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Blue |
| 00810050855501 - Tourniquets | 2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Blue |
| 00810050855525 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Orange |
| 00810050855549 - Tourniquets | 2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Orange |
| 00810050855563 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Flat, Blue |
| 00810050855587 - Tourniquets | 2024-05-03 Tourniquet 1" x 18", Textured, Flat, Orange |
| 10810050855256 - CultureSafe | 2023-06-27Blood Culture Bottle Dispensing Device |
| 10810050855256 - CultureSafe | 2023-06-27 Blood Culture Bottle Dispensing Device |
| 00810050851985 - Medical Face Shield | 2022-12-06 Medical Face Shield |
Trademark Results [CultureSafe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CULTURESAFE 97718878 not registered Live/Pending |
Typenex Medical, LLC 2022-12-15 |
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