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 Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative Evacuated urine specimen container IVD, preservative 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
| 50382903649902 - BD Vacutainer® Urinalysis Transfer Straw Kit | 2024-04-18 KIT URIN TRANSTR 16X100 10.0 UA YEL |
| 50382903649445 - BD Vacutainer® C&S Boric Acid Kit | 2024-04-17 KIT URIN PLH 16X100 10 C&S KAGN CE |
| 50382903649599 - BD Vacutainer® C&S Boric Acid Kit | 2024-04-17 KIT URIN TRANSTR 13X75 C&S KAGN CE HEMO |
| 50382903649919 - BD Vacutainer® Urinalysis Transfer Straw Kit | 2024-04-17 KIT URIN TRANSTR 16X100 8.0 CONI UA YEL |
| 50382903686556 - BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | 2024-04-16 Wingset SLBCS 23x.75 7 Preattached |
| 50382903689205 - BD Vacutainer® FX 5mg 4mg Blood Collection Tubes | 2024-04-16 TUBE GLU PLH 13X75 2.0 BLBLCE GR |
| 50382903689212 - BD Vacutainer® FX 10mg 8mg Blood Collection Tubes | 2024-04-16 TUBE GLU 13X75 4.0 PLH PLBLCE GR |
| 50382903649575 - BD Vacutainer® Urine Complete Cup Kit | 2024-04-15 KIT URIN COMP 13X75 C&S 16X100 CONI UAP |
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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