R Med Pregnancy Test Strip

GUDID B497542100C1001S1

Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests per box. Market--phys

R MEDICAL SUPPLY INC

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B497542100C1001S1
• NIH Device Record Key: 6d465c32-90e3-4789-b756-d75712b63117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R Med Pregnancy Test Strip
• Version Model Number: C1001S-A
• Company DUNS: 788124873
• Company Name: R MEDICAL SUPPLY 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com
• Phone: 9192453600
• Email: sales@rmedicalsupply.com

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B497542100C1001S1 [Primary]
HIBCC	B497542100C1001S11 [Package]; Package: box [50 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-13

Devices Manufactured by R MEDICAL SUPPLY INC

• B49746721COLLSE0 - R Med Collection Set: 2018-03-29 Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter.
• B497542100C1001CA1 - R Med Pregnancy Test Cassettes: 2018-03-29 Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per b
• B497542100C1001S1 - R Med Pregnancy Test Strip: 2018-03-29Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests per box. Market--phys
• B497542100C1001S1 - R Med Pregnancy Test Strip: 2018-03-29 Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests