Ch24 round silicone catheter R9900099

GUDID M640R99000990001

RAND SPA

Multi-purpose percutaneous drainage catheter

• Primary Device ID: M640R99000990001
• NIH Device Record Key: 064729b2-9ac3-4a96-8546-59c4e0d2432b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ch24 round silicone catheter
• Version Model Number: 000
• Catalog Number: R9900099
• Company DUNS: 655010531
• Company Name: RAND SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French
• Length: 600 Millimeter
• Catheter Gauge: 24 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M640R99000990001 [Primary]
HIBCC	M640R99000990002 [Package]; Package: White box [10 Units]; In Commercial Distribution
HIBCC	M640R99000990003 [Package]; Contains: M640R99000990002; Package: Havana box [4 Units]; In Commercial Distribution
HIBCC	M640R99000990004 [Package]; Contains: M640R99000990002; Package: Havana box [2 Units]; In Commercial Distribution

FDA Product Code

• GBX: Catheter, Irrigation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-17
• Device Publish Date: 2017-01-27

On-Brand Devices [Ch24 round silicone catheter]

• M640R99000990001: 000
• M640R99000990012: 001