CautionWear PPE

GUDID 00850836007410

Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.

CAUTION WEAR CORP

Basic male condom, Hevea-latex

• Primary Device ID: 00850836007410
• NIH Device Record Key: b757f568-b50b-42f4-a4b0-85aaf09ae4e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CautionWear PPE
• Version Model Number: CW0001PPE
• Company DUNS: 177056145
• Company Name: CAUTION WEAR CORP
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com
• Phone: 603-598-8500
• Email: anatoli@cautionwearcorp.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850836007397 [Primary]
GS1	00850836007403 [Package]; Contains: 00850836007397; Package: Inner Pack [1000 Units]; In Commercial Distribution
GS1	00850836007410 [Package]; Contains: 00850836007403; Package: Case [4 Units]; In Commercial Distribution
GS1	00850836007427 [Package]; Contains: 00850836007397; Package: Case [4000 Units]; In Commercial Distribution
GS1	00850836007809 [Package]; Contains: 00850836007397; Package: Plastic Bag [24 Units]; In Commercial Distribution
GS1	00850836007816 [Package]; Contains: 00850836007397; Package: Plastic Bag [50 Units]; In Commercial Distribution
GS1	00850836007823 [Package]; Contains: 00850836007397; Package: Plastic Bag [100 Units]; In Commercial Distribution
GS1	00850836007830 [Package]; Contains: 00850836007397; Package: Plastic Bag [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002393

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-20

Devices Manufactured by CAUTION WEAR CORP

• 00850836007762 - CautionWear L.A.Confidential - Dark Desire: 2021-06-29 Male Latex Condom, Contoured, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir
• 00850836007724 - CautionWear L.A.Confidential - Silky Touch: 2021-06-29 Male Latex Condom, Extra Lubricated, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Res
• 00850836007069 - CautionWear L.A.Confidential - Secret Passion: 2021-06-28 Male Latex Condom, Studded, Regular Fit (53 mm), Parallel-Sided, N-9 FREE, Transparent in Color (clear latex), With Reservoir Ti
• 00850836007212 - CautionWear Iron Grip: 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Snugger Fit (49 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal
• 00850836007250 - CautionWear Classic: 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal,
• 00850836007328 - CautionWear Wild Rose: 2018-07-06 Male Latex Condom, Parallel-Sided, Ribbed Texture, Regular Fit (53 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal
• 00850836007342 - FPA: 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Regular Fit (53 mm), Lubricated With Silicon Based Lubricant, Non-Spermicidal
• 00850836007373 - CautionWear Black Ice: 2018-07-06 Male Latex Condom, Parallel-Sided, Smooth Surface, Ultra Thin, Regular Fit (53mm), Lubricated With Silicon-Based Lubricant, Non-