Hemoglobin Control Solution

GUDID 06935740733854

Urit Medical Electronic Co., Ltd.

Haemoglobin detection IVD, control

• Primary Device ID: 06935740733854
• NIH Device Record Key: bd3acfdb-39b4-4439-9e9f-a5e6d0ba70b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoglobin Control Solution
• Version Model Number: HQ-A,1mL/bottle×3/box
• Company DUNS: 653742429
• Company Name: Urit Medical Electronic Co., Ltd.
• Device Count: 3
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06935740733854 [Primary]
GS1	86935740733850 [Unit of Use]

FDA Product Code

• GGM: Control, Hemoglobin

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: 2024-07-22
• Device Publish Date: 2024-07-12

Devices Manufactured by Urit Medical Electronic Co., Ltd.

• 06935740726993 - Hemoglobin Test Strip: 2024-09-30
• 06935740726986 - Blood Lipid Test Strip: 2024-07-22
• 06935740727006 - Uric Acid Test Strip: 2024-07-22
• 06935740727013 - Uric Acid Test Strip: 2024-07-22
• 06935740727020 - Uric Acid Test Strip: 2024-07-22
• 06935740727037 - Uric Acid Test Strip: 2024-07-22
• 06935740733830 - Hemoglobin Test Strip: 2024-07-22
• 06935740733847 - Hemoglobin Test Strip: 2024-07-22