BD Vacutainer® Urine Complete Cup Kit 364956

GUDID 50382903649568

KIT URIN COMP 13X75 C&S 16X100 CONI UA

BECTON, DICKINSON AND COMPANY

Evacuated urine specimen container IVD, preservative

• Primary Device ID: 50382903649568
• NIH Device Record Key: 8c22329a-ac4b-44b1-9f27-df7f2f2dbfa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Urine Complete Cup Kit
• Version Model Number: 364956
• Catalog Number: 364956
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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

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
• 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	00382903649563 [Unit of Use]
GS1	50382903649568 [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

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

[50382903649568]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-07-02
• Device Publish Date: 2020-11-16

On-Brand Devices [BD Vacutainer® Urine Complete Cup Kit]

• 00382903649563: KIT URIN COMP 13X75 C&S 16X100 CONI UA
• 50382903649575: KIT URIN COMP 13X75 C&S 16X100 CONI UAP
• 50382903649568: KIT URIN COMP 13X75 C&S 16X100 CONI UA