HemosIL Factor V Deficient Plasma (10 X 1 mL) 00020011500

GUDID 08426950484745

HemosIL Factor V Deficient Plasma (10 X 1 mL)

INSTRUMENTATION LABORATORY COMPANY

Coagulation factor V IVD, kit, clotting

• Primary Device ID: 08426950484745
• NIH Device Record Key: a037a8f7-e3b9-4b5c-bf07-27cedd5982ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemosIL Factor V Deficient Plasma (10 X 1 mL)
• Version Model Number: 00020011500
• Catalog Number: 00020011500
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 10
• 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: 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: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is 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 deficient plasma is stable until the expiration date shown on the vial when stored at 2-8°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950484745 [Primary]
GS1	18426950484742 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023839

FDA Product Code

• GGN: PLASMA, COAGULATION CONTROL

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: 2021-07-08
• Device Publish Date: 2016-09-23

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• 00195226000542 - ACL TOP 770s: 2024-05-23 ACL TOP 770s
• 00195226000559 - ACL TOP 570: 2024-05-23 ACL TOP 570
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