PEG

GUDID 10858400005104

PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution.

AMERICAN NATIONAL RED CROSS

Polyethylene glycol (PEG) immunohaematology reagent IVD

• Primary Device ID: 10858400005104
• NIH Device Record Key: eff243f5-85a0-4c0f-bb3c-6990be8d4932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEG
• Version Model Number: 510179
• Company DUNS: 003255213
• Company Name: AMERICAN NATIONAL RED CROSS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858400005107 [Primary]
GS1	10858400005104 [Package]; Contains: 00858400005107; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• KSG: Media, Potentiating For In Vitro Diagnostic Use

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: 2018-10-18
• Device Publish Date: 2018-09-17

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