Sapphire Suction Reservoir 2001

GUDID 00854373007070

Sapphire Suction Reservoir

GREER MEDICAL, INC.

Closed-wound/centesis drainage receptacle

• Primary Device ID: 00854373007070
• NIH Device Record Key: 6219c447-086e-46d7-b315-a3f5a8a9051b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire Suction Reservoir
• Version Model Number: 2001 Pouch
• Catalog Number: 2001
• Company DUNS: 800169260
• Company Name: GREER MEDICAL, INC.
• 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

Customer Support Contacts

• Phone: 805-962-5883
• Email: info@greer-medical.com

Device Dimensions

• Total Volume: 100 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 105 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854373007070 [Primary]
GS1	00854373007087 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905733

FDA Product Code

• GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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: 2018-07-06
• Device Publish Date: 2017-05-10

Devices Manufactured by GREER MEDICAL, INC.

• 00854373007001 - SeromaCath: 2018-07-06 Original SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm)
• 00854373007025 - SeromaCath: 2018-07-06 Long SeromaCath Wound Drainage System 14G (2,1mm) x 3.5" (8,9cm)
• 00854373007056 - SeromaCath: 2018-07-06 Blunt SeromaCath Wound Drainage System 14G (2,1mm) x 2" (5cm)
• 00854373007070 - Sapphire Suction Reservoir: 2018-07-06Sapphire Suction Reservoir
• 00854373007070 - Sapphire Suction Reservoir: 2018-07-06 Sapphire Suction Reservoir
• 00854373007094 - SurgiFish: 2018-03-29 SurgiFish Viscera Retainer