ESR-Chex 214108

GUDID 00844509001645

A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vials each of level 1 & 2.

STRECK, INC.

Erythrocyte sedimentation rate (ESR) IVD, control

• Primary Device ID: 00844509001645
• NIH Device Record Key: 4c770769-6e9b-4d4e-a617-c3ae48a4cc65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESR-Chex
• Version Model Number: 214108
• Catalog Number: 214108
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-228-6090
• Email: custserv@streck.com

Device Dimensions

• Total Volume: 9 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509001645 [Primary]

FDA Product Code

• JPH: Test, Erythrocyte Sedimentation Rate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

On-Brand Devices [ESR-Chex ]

• 00844509001652: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 6 vial
• 00844509001645: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vial
• 00844509001638: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 2 vial
• 00844509001621: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 1 vial
• 20844509001618: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vial
• 20844509001601: A two-level hematology control used to monitor erythrocyte sedimentation rates. Contains 4 vial