Aplicare Lubricating Jelly 82-280

GUDID 00618407002802

Lubricating Jelly

APLICARE, INC.

General-body orifice lubricant, sterile General-body orifice lubricant, sterile General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant General-body orifice lubricant

• Primary Device ID: 00618407002802
• NIH Device Record Key: f7521990-6788-4e20-be01-96fb761ba134
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aplicare Lubricating Jelly
• Version Model Number: 82-280
• Catalog Number: 82-280
• Company DUNS: 058377631
• Company Name: APLICARE, INC.
• Device Count: 1
• 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: 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(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com
• Phone: +1(800)760-3236
• Email: aplicarecustomerservice@clorox.com

Device Dimensions

• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram
• Device Size Text, specify: 0
• Weight: 3 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618407002802 [Primary]
GS1	10618407002809 [Package]; Package: box [150 Units]; In Commercial Distribution
GS1	20618407002806 [Package]; Package: bag [30 Units]; In Commercial Distribution
GS1	30618407002803 [Package]; Contains: 10618407002809; Package: case [6 Units]; In Commercial Distribution
GS1	40618407002800 [Package]; Package: case [1000 Units]; In Commercial Distribution
GS1	50618407002807 [Package]; Contains: 20618407002806; Package: case [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K912132

FDA Product Code

• FHX: JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT

Sterilization

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

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

[00618407002802]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-17

On-Brand Devices [Aplicare Lubricating Jelly]

• 00618407002819: Lubricating Jelly
• 00618407002802: Lubricating Jelly