BD Vacutainer® Urinalysis Cup Kit 364946

GUDID 00382903649464

KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL

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: 00382903649464
• NIH Device Record Key: 15cf3193-a567-4b10-864e-fc0d44bb15a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Urinalysis Cup Kit
• Version Model Number: 364946
• Catalog Number: 364946
• 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

Device Dimensions

• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 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	00382903649464 [Unit of Use]
GS1	50382903649469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790366

FDA Product Code

• JTW: SYSTEM, TRANSPORT, AEROBIC

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

Radiation Sterilization

[00382903649464]

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

On-Brand Devices [BD Vacutainer® Urinalysis Cup Kit]

• 00382903649891: KIT URIN CUP 16X100 8.0 CONI UA YEL
• 00382903649815: KIT URIN CUP PLC 16X100 10.0 UA YEL
• 00382903649464: KIT URIN CUP 16X100 8.0 CONI UAP RD/YEL