DISPETTE® FH1650

GUDID 07612964000809

DISPETTE 2 CITRATE

Guest Scientific AG

Erythrocyte sedimentation rate (ESR) IVD, kit

• Primary Device ID: 07612964000809
• NIH Device Record Key: c038d0ba-a0da-4939-8c6a-e75f32d47d22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPETTE®
• Version Model Number: FH1650
• Catalog Number: FH1650
• Company DUNS: 483342734
• Company Name: Guest Scientific AG
• Device Count: 100
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612964000762 [Primary]
GS1	07612964000786 [Unit of Use]
GS1	07612964000809 [Package]; Contains: 07612964000762; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• JPH: Test, Erythrocyte Sedimentation Rate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [DISPETTE®]

• 07612964013656: DISPETTE LEVELING STAND
• 07612964013540: DISPETTE PLUGGED
• 07612964013410: WINPETTE
• 07612964013335: DISPETTE ONE
• 07612964013311: DISPETTE 2 SALINE
• 07612964000809: DISPETTE 2 CITRATE
• 07612964013113: DISPETTE ONE