ROTEM® 503-09-US

GUDID 04260160470082

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to pro

Tem Innovations GmbH

Multiple coagulation factor IVD, reagent

• Primary Device ID: 04260160470082
• NIH Device Record Key: 883c7c7c-46d8-4cc7-95e2-7285780262b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTEM®
• Version Model Number: hep-tem®
• Catalog Number: 503-09-US
• Company DUNS: 506692297
• Company Name: Tem Innovations GmbH
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260160470082 [Primary]
GS1	04260160470501 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083842

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [ROTEM®]

• 04260160470587: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470242: The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation
• 04260160470112: ROTROL P is a quality control material for monitoring accuracy and precision of tests carried ou
• 04260160470105: ROTROL N is a quality control material for monitoring accuracy and precision of tests carried ou
• 04260160470099: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470082: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470075: The FIBTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboel
• 04260160470068: The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboela
• 04260160470044: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470020: The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory envir
• 04260160470372: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470624: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470617: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i
• 04260160470600: The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use i