LEADER 5741855

GUDID 50096295141516

LDR One Step Pregnancy Test 1 ea

Cardinal Health 110, Inc.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, agglutination, rapid

• Primary Device ID: 50096295141516
• NIH Device Record Key: 4ed6baa5-9dc5-4b39-a2b5-09af109f431e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEADER
• Version Model Number: 5741855
• Catalog Number: 5741855
• Company DUNS: 063997360
• Company Name: Cardinal Health 110, Inc.
• 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: 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)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx
• Phone: +1(800)200-6313
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00096295141511 [Primary]
GS1	50096295141516 [Package]; Contains: 00096295141511; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150022

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: 2022-01-24
• Device Publish Date: 2022-01-14

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• 50096295141547: LDR One Step Pregnancy Test 2 tests
• 50096295141530: LDR Early Detection Pregnancy Test 3 ea
• 50096295141523: LDR One Step Pregnancy Test 2 ea
• 50096295141516: LDR One Step Pregnancy Test 1 ea
• 50096295141509: LDR Early Detection Pregnancy Test 2 ea
• 50096295141158: LDR Advanced Wound Care Silicone Tape 1 in x 4 yards 1 each
• 50096295141172: LDR Sterile Transparent Waterseal Dressing 4in x 4.75in 4 ea
• 50096295141196: LDR Paper Tape with Dispenser 1 inch x 10 yards 1 roll
• 30096295141147: LDR No Hurt Wrap 3inx80in 1 ea
• 50096295141134: LDR Paper Tape 2 in x 10 yards 1 roll
• 50096295142469: LDR Waterproof Sterile Large Adhesive Pads 3x4in 6 count
• 50096295142452: LDR Flexible Fabric Adhesive Bandage Sterile 100 each assorted
• 50096295142445: LDR Heavy Duty Waterproof Adhesive Bandages Sterile 2x4in 10 count
• 50096295142438: LDR Cushioned Waterproof Knee & Elbow Bandages Sterile 2x4in 8 count
• 50096295142421: LDR Heavy Duty Flexible Fabric Adhesive Bandages Sterile 2x4 inch 10 count
• 50096295142414: LDR Flexible Fabric Adhesive Bandage Sterile 2x4in 10 each
• 00096295135381: LDR First Aid Kit 70 pieces
• 00096295135374: LDR First Aid Kit 140 pieces
• 50096295142827: LDR Sheer Adhesive Bandage Sterile 3/4" x 3" 100 count
• 50096295142735: LDR Nitrile Exam Gloves Extra Large non-sterile Powder-free 100 count
• 50096295142728: LDR Nitrile Exam Gloves Large non-sterile Powder-free 100 count
• 50096295142711: LDR Nitrile Exam Gloves Medium non-sterile Powder-free 100 count
• 50096295142704: LDR Nitrile Exam Gloves Small non-sterile Powder-free 100 count
• 50096295142698: LDR Vinyl Exam Gloves Small non-sterile Powder-free 100 count
• 50096295142681: LDR Vinyl Exam Gloves Extra large non-sterile Powder-free 100 count
• 50096295142674: LDR Vinyl Exam Gloves Large non-sterile Powder-free 100 count
• 50096295142667: LDR Vinyl Exam Gloves Medium non-sterile Powder-free 100 count
• 50096295143855: LDR Talking Blood Pressure Monitor with Wide Range Arm Cuff 1 monitor Kit
• 50096295143473: LDR Easy Ovulation Test Analog 10ct + 1 Analog Pregnancy Test