Meijer

GUDID 10760236264825

MEIJER DPS Advanced Early Result

MEIJER, INC.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10760236264825
• NIH Device Record Key: 08baf8cb-a759-4f23-bb1f-7ea8ab78ab6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meijer
• Version Model Number: Advanced Early Result Pregnancy Test
• Company DUNS: 006959555
• Company Name: MEIJER, INC.
• Device Count: 2
• 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx
• Phone: 1-800-899-7353
• Email: xx@xx.xx

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
• 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	00633472000508 [Unit of Use]
GS1	00760236264828 [Primary]
GS1	10760236264825 [Package]; Contains: 00760236264828; Package: Shipping Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042280

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

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: 2020-10-12
• Device Publish Date: 2020-10-02

On-Brand Devices [Meijer ]

• 00713733914567: Contact Lens Case, Screw Top, 12 Pack
• 00713733914550: Contact Lens Case, Screw Top
• 00713733914543: Contact Lens Case, Screw Top, 6 Pack
• 00713733446105: Meijer Talking Dog Digital Thermometer
• 10713733353943: Meijer Ultra Premium Automatic Arm Digital BP Monitor
• 10713733264829: Meijer Infrared Digital Thermometer
• 10713733261088: Meijer Mini Digital Thermometer
• 00713733261074: Meijer Basal Thermometer
• 10713733260845: Meijer Temple Touch Mini Thermometer
• 10713733086148: Wart Freezer Cryogenic Treatment 1-Step Wart Remover
• 00708820985513: Meijer 2 Second Flexible Tip Digital Thermometer
• 00708820944787: Meijer Tens Replacement Pads
• 00708820944770: Meijer Tens Unit for Back and Extremities
• 00708820575394: Meijer Blood Pressure Monitor Automatic Wrist
• 00760236653332: Meijer Aneroid Self-Taking Home BP Kit
• 20708820342211: MEIJER EARLOOP FACE MASK 25 CT
• 00708820342200: MEIJER CONE STYLE FACE MASK 10 CT
• 00708820268807: Meijer Pedia Pets 3-Pack 20-Second Flexible Tip Digital Thermometer
• 00708820268791: Meijer Economy Pulse Oximeter
• 10708820267791: Meijer Digital wrist BP Unit
• 10708820267739: Meijer Automatic Digital BP Unit
• 00708820265547: Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
• 00708820228818: Anti Viral Face Mask 10 count
• 00708820191716: Meijer Deluxe Pulse Oximeter
• 10708820121277: Meijer 8-Second Flexible Tip Digital Thermometer
• 00708820058781: Meijer Premium Display Arm Cuff DBPM with Clamp Cuff
• 10708820047744: Meijer Probe Covers
• 10708820047737: Meijer Deluxe Temple Touch Thermometer
• 10708820047720: Meijer Instant Ear Thermometer
• 10708820047706: Meijer 30 Second Flex Tip Thermometer
• 30708820047670: Meijer 8-Second Flexible Tip Digital Thermometer
• 10708820042541: Meijer Deluxe Shoulder, Neck, and Back Heating Pad Wrap
• 00760236653387: Meijer Digital wrist BP Unit
• 00760236653370: Meijer Premium Automatic Digital BP Unit
• 00760236653363: Meijer Automatic Digital BP Unit
• 10719283278002: Meijer TENS Pulse Messager with 2 Replacement Pads
• 10713733916391: Meijer Premium Automatic Digital Blood Pressure Monitor
• 10713733353950: Meijer Deluxe Temple Touch Thermometer
• 10713733132326: Meijer Basal Flexible Tip Digital Thermometer
• 10719283501308: Meijer 12" x 15" Deluxe Heating Pad
• 10719283551372: Decorated, pineapple bandages, Sterile Adhesive Bandages, Antibacterial Pad, all one size, 3/4 i
• 10719283500226: Drug Free, Nasal Strips, Clear Medium
• 10719283500219: Drug Free, Nasal Strips, Clear Large
• 10719283500202: Drug Free, Nasal Strips, Clear Extra Strength
• 10719283500196: Drug Free, Nasal Strips, Tan Large
• 10719283500189: Drug Free, Nasal Strips, Tan Extra Strength
• 10719283500172: Drug Free, Nasal Strips, Clear Medium
• 10713733521694: Decorated unicorn bandages, Sterile Adhesive Bandages, Antibacterial Pads, all one size, 3/4 x 3
• 10713733521670: Decorated, dragon bandages, Sterile Adhesive Bandages, Antibacterial Pad, all one size, 3/4 in x
• 10713733521595: Smart-Flex, Sterile Adhesive Bandages, assorted sizes