BD Intermittent RTU12M

GUDID 16948796203957

BD Ready-To-Use Hydrophilic Catheter

Hangzhou Bever Medical Devices Co., Ltd.

Single-administration urethral drainage catheter

• Primary Device ID: 16948796203957
• NIH Device Record Key: ef3b7164-8200-476e-bad6-c1bfaa524f55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Intermittent
• Version Model Number: RTU12M
• Catalog Number: RTU12M
• Company DUNS: 528185295
• Company Name: Hangzhou Bever Medical Devices Co., Ltd.
• Device Count: 1
• 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

• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch
• Catheter Gauge: 12 French
• Catheter Length: 16 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight and Keep Dry.
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948796203950 [Primary]
GS1	16948796203957 [Package]; Contains: 06948796203950; Package: CA [30 Units]; In Commercial Distribution
GS1	26948796203954 [Package]; Package: BX [270 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192468

FDA Product Code

• GBM: Catheter, Urethral

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-01
• Device Publish Date: 2021-01-23

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• 16948796203964: BD Ready-To-Use Hydrophilic Catheter
• 16948796203957: BD Ready-To-Use Hydrophilic Catheter