DISPETTE® FH1600

GUDID 07612964013311

DISPETTE 2 SALINE

Guest Scientific AG

Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit Erythrocyte sedimentation rate (ESR) IVD, kit

• Primary Device ID: 07612964013311
• NIH Device Record Key: 2514317f-6fd6-4e11-bdb3-b023a4fc0dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPETTE®
• Version Model Number: FH1600
• Catalog Number: FH1600
• 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	07612964013304 [Primary]
GS1	07612964013311 [Package]; Contains: 07612964013304; Package: CASE [10 Units]; In Commercial Distribution
GS1	07612964013328 [Unit of Use]
GS1	07612964013342 [Unit of Use]

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