SaliCaps RE69991.

GUDID 04049325003606

SaliCaps - 100 Tubes

IBL International GmbH

General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive, non-sterile General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium General specimen container IVD, no additive/medium

• Primary Device ID: 04049325003606
• NIH Device Record Key: 09556c69-da69-4a9c-ae36-322c21072ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SaliCaps
• Version Model Number: RE69991.
• Catalog Number: RE69991.
• Company DUNS: 312694785
• Company Name: IBL International GmbH
• 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: true
• 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: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com
• Phone: +49405328910
• Email: IBL@Tecan.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049325003606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040923

FDA Product Code

• JLS: Radioimmunoassay, Progesterone

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: 2021-01-06
• Device Publish Date: 2020-12-29

On-Brand Devices [SaliCaps]

• 04049325003613: SaliCaps - 500 Tubes
• 04049325003606: SaliCaps - 100 Tubes