BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube 364958
GUDID 30382903649588
TUBE URIN PLH 13X75 4.0 C&S KAGN CE
BECTON, DICKINSON AND COMPANY
Evacuated urine specimen container IVD, preservative| Primary Device ID | 30382903649588 |
| NIH Device Record Key | f43b0cd2-e397-439d-a11b-c4a29eb203cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD Vacutainer® Boric Acid Sodium Borate/Formate C&S Urine Tube |
| Version Model Number | 364958 |
| Catalog Number | 364958 |
| Company DUNS | 001292192 |
| Company Name | BECTON, DICKINSON AND COMPANY |
| Device Count | 1000 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382903649587 [Unit of Use] |
| GS1 | 30382903649588 [Package] Contains: 50382903649582 Package: Shelfpack [100 Units] In Commercial Distribution |
| GS1 | 50382903649582 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K024240
FDA Product Code
| JSM | CULTURE MEDIA, NON-PROPAGATING TRANSPORT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
[30382903649588]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-07-22 |
| Device Publish Date | 2020-11-16 |
Devices Manufactured by BECTON, DICKINSON AND COMPANY
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| 60382904454755 - BD BACTEC™ 9240 | 2024-11-12 BD BACTEC™ 9240 |
| 60382904455707 - BD BACTEC™ 9120 | 2024-11-12 BD BACTEC™ 9120 |
| 00382904458003 - BD BACTEC™ 9050 | 2024-11-11 BD BACTEC™ 9050 |
| 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube | 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube |
| 00382906639844 - Horizon | 2024-10-22 CD138 (MI15) BV421 ASR |
| 00382906651204 - Horizon | 2024-10-22 CD197 (2-L1-A) APC-R700 ASR |
| 00382906651297 - Horizon | 2024-10-22 CD194 (1G1) BV421 ASR |
Trademark Results [BD Vacutainer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD VACUTAINER 78264506 2858038 Live/Registered |
Becton, Dickinson and Company 2003-06-19 |
 BD VACUTAINER 77000481 3257557 Dead/Cancelled |
Becton, Dickinson and Company 2006-09-15 |
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