Care One

GUDID 00633472000133

FPPL Care One DPS +/-

Ahold U.S.A., Inc.

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

• Primary Device ID: 00633472000133
• NIH Device Record Key: f1c45999-0e43-48c9-8cb7-3f52a102afea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care One
• Version Model Number: One Step Pregnancy Test
• Company DUNS: 170199058
• Company Name: Ahold U.S.A., 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: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 800-899-7353
• Email: xx@xx.xx
• Phone: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00041520171276 [Primary]
GS1	00050428256923 [Primary]
GS1	00633472000133 [Unit of Use]
GS1	10041520171273 [Package]; Contains: 00041520171276; Package: shipper [24 Units]; In Commercial Distribution
GS1	10050428256920 [Package]; Contains: 00050428256923; 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: 2021-04-30
• Device Publish Date: 2021-04-22

On-Brand Devices [Care One]

• 10341520310109: Sterile Saline Wound Wash. Packaged in an aerosol (BOV) can.
• 00341520005879: 4mm 33G Pen Needle with Remover- Unifine Pentips Plus
• 10688267540162: MAXIPAD REGULAR w/WINGS UNSCENTED
• 10688267540155: MAXIPAD LONG SUPER w/WINGS UNSCENTED
• 10688267540148: MAXIPAD OVERNIGHT w/WINGS UNSCENTED
• 10688267131643: MAXIPAD LONG SUPER w/WINGS UNSCENTED
• 10688267131513: MAXIPAD ULTRA THIN OVERNIGHT w/WINGS UNSCENTED
• 10688267039352: MAXIPAD OVERNIGHT w/WINGS UNSCENTED
• 00068826703116: MAXIPAD LONG SUPER MULTI-CHANNEL WINGLESS UNSCENTED
• 10688267022033: MAXIPAD LONG SUPER MULTI-CHANNEL WINGLESS UNSCENTED
• 00688267022029: MAXIPAD REGULAR UNSCENTED
• 10688267022019: PANTILINER LONG CONTOUR UNSCENTED
• 10688267022002: PANTILINER LONG CONTOUR UNSCENTED
• 10688267021982: MAXIPAD ULTRA THIN LARGE SUPER w/WINGS UNSCENTED
• 10688267021975: MAXIPAD ULTRA THIN OVERNIGHT w/WINGS UNSCENTED
• 10041520157574: MAXIPAD ULTRA THIN EXHEAVY OVERNIGHT w/WINGS UNSCENTED
• 10041520157567: MAXIPAD ULTRA THIN EXLARGE SUPER w/WINGS UNSCENTED
• 10041520141306: MAXIPAD ULTRA THIN REGULAR w/WINGS UNSCENTED
• 10041520141290: MAXIPAD ULTRA THIN LARGE SUPER w/WINGS UNSCENTED
• 10041520141283: PANTILINER LONG EVERYDAY UNSCENTED
• 10041520021417: MAXIPAD EXTRA HEAVY w/WINGS UNSCENTED
• 00041520870902: Sterile 3% Hydrogen Peroxide (Lens Care System)
• 00688267567841: Dual Mode Infrared Thermometer
• 00633472000041: Digital Pregnancy Test
• 00633472000133: FPPL Care One DPS +/-
• 00041520171269: FPPL Care One SPS +/-
• 00041520869166: Multi-Purpose Solution (For Soft Contact Lenses)
• 00041520865281: Sterile Multi-Purpose Solution
• 00041520105158: Care One Automatic Digital BP Monitor Jumbo Display-Arm, Wide Range Cuff
• 00041520105141: Care One Automatic Digital BP Monitor Arm Wide Range Cuff
• 00041520105134: Care One Pulse Oximeter
• 00041520105103: Care One Automatic Digital Blood Pressure Wrist Monitor
• 10041520113426: 055544
• 10041520113402: 054793
• 00041520113375: 055076
• 30688267567583: AHOST25
• 30041520156076: AHOST03
• 30041520110443: AHOST01
• 30041520110320: AHOST02
• 00041520876461: 532181
• 10041520135428: PLPL Care One DPS Early Result