HemosIL SynthAFax 00020007400

GUDID 08426950087649

HemosIL SynthAFax

INSTRUMENTATION LABORATORY COMPANY

Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting Activated partial thromboplastin time (APTT) IVD, kit, clotting

• Primary Device ID: 08426950087649
• NIH Device Record Key: 6be6d48b-9aba-4b2a-a7e8-79dc73a8e03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL SynthAFax
• Version Model Number: 00020007400
• Catalog Number: 00020007400
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• 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: false
• 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: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950087649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955638

FDA Product Code

• GFO: ACTIVATED PARTIAL THROMBOPLASTIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-09
• Device Publish Date: 2016-09-23

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