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

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