Le soothe Latex PF L/R FIT Exam Natural 7.0 43770N

GUDID D76643770N2

GLV LE SOOTHE NP LATEX PF L/R FIT NATURAL STD BX 7.0*50 PR

Smarthealth, Inc.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: D76643770N2
• NIH Device Record Key: 7638c017-53ef-41e2-8481-c8beffb0cada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Le soothe Latex PF L/R FIT Exam Natural 7.0
• Version Model Number: 43770N
• Catalog Number: 43770N
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 50
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com
• Phone: 1-800-522-0800
• Email: info@smartpractice.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D76643770N0 [Unit of Use]
HIBCC	D76643770N1 [Primary]
HIBCC	D76643770N2 [Package]; Contains: D76643770N1; Package: case [10 Units]; In Commercial Distribution

FDA Product Code

• LYY: Latex Patient Examination Glove

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by Smarthealth, Inc.

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• D7664311072 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM*200
• D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200
• D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200
• D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL: 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200
• D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS*: 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100
• D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM: 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100
• D766408732 - QUALITOUCH LATEX PF EXAM NATURAL CF MD: 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF MED*100