Healgen HURS-1T

GUDID 20816490021104

1 parameter Urine Strip

Healgen Scientific Limited Liability Company

Urine ketone IVD, kit, colorimetric dipstick, rapid

• Primary Device ID: 20816490021104
• NIH Device Record Key: 72de537d-c61e-4aba-8f1d-c968ce7d749f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healgen
• Version Model Number: HURS-1T
• Catalog Number: HURS-1T
• Company DUNS: 031802328
• Company Name: Healgen Scientific Limited Liability Company
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816490021100 [Primary]
GS1	10816490021107 [Package]; Contains: 00816490021100; Package: Inner Pack [100 Units]; In Commercial Distribution
GS1	20816490021104 [Package]; Contains: 10816490021107; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111999

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: 2019-10-07
• Device Publish Date: 2017-05-09

On-Brand Devices [Healgen]

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• 20816490022002: 12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsCRE/SG/pH
• 20816490021999: 12 Panel DOA Test Dipcard
• 20816490021982: 6 Panel DOA Test Clear Round Cup
• 20816490021975: 12 Panel DOA Test Clear Round Cup
• 20816490021968: 12 Panel DOA Test clear Round Cup +Adulterant Test StripsOXI/SG/pH
• 20816490021951: 5 Panel DOA Test Clear Round Cup
• 20816490021944: 5 Panel DOA Test Clear Round Cup
• 20816490021937: 5 Panel DOA Test clear Round Cup With Clicker
• 20816490021913: 3 Panel DOA Test Dipcard
• 20816490021890: 10 Panel DOA Test Dipcard
• 20816490021883: 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
• 20816490021876: 6 Panel DOA Test clear Round Cup With Clicker
• 20816490021869: 7 Panel DOA Test clear Round Cup With Clicker
• 20816490021852: 17 Panel DOA Test clear Round Cup
• 20816490021838: 12 Panel DOA Test clear Round Cup With Clicker;+Adulterant Test StripsOXI/SG/pH
• 20816490021821: 12 Panel DOA Test Clear Flat Cup
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• 20816490021784: LH Ovulation Rapid Test Strip(Urine,25mIU/mL)
• 20816490021777: 7 Panel DOA Test Dipcard
• 20816490021760: 11 Panel DOA Test Dipcard
• 20816490021753: 12 Panel DOA Test clear Round Cup With Clicker+Adulterant Test Strips CRE/SG/pH
• 20816490021746: 12 Panel DOA Test clear Round Cup With Clicker;+ Adulterant Test StripsOXI/SG/pH
• 20816490021739: 10 Panel DOA Test clear Round Cup With Clicker
• 20816490021722: 7 Panel DOA Test clear Round Cup With Clicker
• 20816490021715: 12 Panel DOA Test Dipcard
• 20816490021708: 7 Panel DOA Test Dipcard
• 20816490021692: 11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
• 20816490021685: 6 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT
• 20816490021678: 10 Panel DOA Test clear Round Cup With Clicker+Adulterant Test StripsOXI/SG/pH
• 20816490021661: 5 Panel DOA Test clear Round Cup With Clicker
• 20816490021654: 12 Panel DOA Test clear Round Cup With Clicker
• 20816490021647: 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
• 20816490021630: 12 Panel DOA Test clear Round Cup With Clicker
• 20816490021623: 5 Panel DOA Test clear Round Cup With Clicker
• 20816490021616: 5 Panel DOA Test clear Round Cup With Clicker
• 20816490021609: Single Panel DOA Test Dipcard
• 20816490021593: 12 Panel DOA Test clear Round Cup With Clicker
• 20816490021586: 10 Panel DOA Test clear Round Cup With Clicker
• 20816490021579: 12 Panel DOA Test Clear Flat Cup + Adulterant Test Strips OXI/SG/CRE
• 20816490021562: 10 Panel DOA Test Dipcard
• 20816490021555: 12 Panel DOA Test Dipcard
• 20816490021548: 10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
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• 20816490021524: 10 Panel DOA Test Dipcard
• 20816490021517: 10 Panel DOA Test Dipcard
• 20816490021500: 9 Panel DOA Test Dipcard
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