Signature Care

GUDID 10021130790057

CB8 Digital Pregnancy Stick Signature Care DPS Digital Early

BETTER LIVING BRANDS LLC

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

• Primary Device ID: 10021130790057
• NIH Device Record Key: 61ef4bc2-58c8-4039-b4ec-baf725122b93
• Commercial Distribution Discontinuation: 2022-02-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Signature Care
• Version Model Number: Digital Pregnancy Test
• Company DUNS: 080349866
• Company Name: BETTER LIVING BRANDS LLC
• 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: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• Email: xx@xx.xx
• Phone: 1-888-723-3929
• 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	00021130790050 [Primary]
GS1	00633472000041 [Unit of Use]
GS1	10021130790057 [Package]; Contains: 00021130790050; Package: Shipping case [24 Units]; Discontinued: 2022-02-02; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060128

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-03
• Device Publish Date: 2016-10-26

On-Brand Devices [Signature Care ]

• 10321130795992: The Secret Life of Pets 2 Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130795671: Extra Large Strong Strips Adhesive Bandages, one size, 1 3/4 in x 4 in (44 mm x 101 mm)
• 10321130795657: Sheer Adhesive Bandages, assorted, 2 in x 4 in (50 mm x 101 mm); 1 in x 3 in (25 mm x 76 mm); 3/
• 10321130794568: Antibacterial Waterproof Plastic Adhesive Bandages, 1 in x 3 in (25 mm x 76 mm)
• 10321130794537: Plastic Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130794520: Sheer Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130794513: Antibacterial Fabric Adhesive Bandages, assorted, 1 in x 3 in (25 mm x 76 mm); 3/4 in x 3 in (19
• 10321130794490: Butterfly Closures Wound Closures, one size, 1 3/4 in x 3/8 in (44 mm x 9 mm)
• 10321130794452: Antibacterial Strong Strips Adhesive Bandages, 1 in x 3 /14 in (25 mm x 82 mm)
• 10321130794421: Hydrocolloid Adhesive Bandages, one size, 7/8 in x 1 5/8 in (22 mm x 41 mm)
• 10321130794414: Antibacterial Fabric Adhesive Bandages, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130788819: Neon Decorated Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130788796: Sheer Spot Bandages, one size, 7/8 in (22 mm)
• 10321130787874: Neck, Shoulder & Wrist Heat Wrap
• 10321130781100: Extra Large Antibacterial Waterproof Strong Strips Adhesive Bandages, 2 in x 4 in (50 mm x 101 m
• 10321130780493: Antibacterial Fabric Adhesive Bandages, assorted, Knuckle 1 1/2 in x 3 in (38 mm x 76 mm); Finge
• 10321130780486: Extra Large Sheer Adhesive Bandages, one size, 2 in x 4 in (50 mm x 101 mm)
• 10321130780479: Clear Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130763076: Back & Hip Heat Wrap
• 10321130144721: SpongeBob Squarepants Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130078217: Emoji Adhesive Bandages, one size, 3/4 in x 3 in (19 mm x 76 mm)
• 10321130778698: Drug-Free Nasal Strips, Tan Extra Strength
• 10321130762857: Drug-Free Nasal Strips, Clear Medium
• 10321130762840: Drug-Free Nasal Strips, Tan Large
• 10021130798053: Power Toothbrush, Polaris, Soft
• 10021130701336: Floss, Extra Comfort, Mint, 40M
• 10021130701046: Flosser, Kids Jungle, 36
• 10021130700384: Floss, Tape, Mint, 50YD
• 10021130700315: Floss, Mint, 100YD
• 10021130700308: Floss, Mint, 50M
• 80021130700260: Flosser, Compact Pick, Mint
• 00021130700196: Floss, Unwaxed, 100YD
• 10021130700186: Floss, Waxed, 100YD
• 10021130700162: Flosser, Compact Pick, Mint
• 10321130148101: Sheer Adhesive Bandages, assorted, 3/4 IN x 3 IN (19 mm x 76 mm), 2 1/4 IN x 3 IN (57 mm x 76 mm
• 10321130136627: BP3MK1-2EASC
• 10321130136603: BP3AG1-1PASC
• 10321130136610: BP3AR1-1PASC
• 10021130771292: ALBERTSON DIGISCAN THERMOMETER
• 10321130172175: Neck, Shoulder & Wrist Heat Wrap
• 10021130163837: Signature Care Pregnancy 2ct Digital Early Blue
• 10021130163820: Signature Care Pregnancy 1ct Visual Blue Cap
• 10021130790057: CB8 Digital Pregnancy Stick Signature Care DPS Digital Early
• 20321130780247: Personal Lubricating Jelly 4oz. (113g)
• 10021130790002: Signature Care DPS Early Result
• 00021130788361: FPPL Signature Care SPS +/- (ER)
• 10321130195907: First Aid Kit, First Aid, Essentials, 140 items including 1 carrying case: 2 - Sheer Bandages 2
• 10321130195891: First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 5 - Fabric Bandages 1 I