O-Cal-ette 009900

GUDID 00308130099001

Nursing Cup

PHARMICS, INC.

Nipple pad/ring Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable Nipple pad/ring, reusable

• Primary Device ID: 00308130099001
• NIH Device Record Key: e0175948-c0dc-45d7-af50-219bee1eecd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Cal-ette
• Version Model Number: 9900
• Catalog Number: 009900
• Company DUNS: 058560996
• Company Name: PHARMICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com
• Phone: +1(801)966-4138
• Email: pb@pharmics.com

Device Dimensions

• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch
• Outer Diameter: 3.38 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00308130099001 [Primary]

FDA Product Code

• HFS: SHIELD, NIPPLE

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: 2018-02-17