ExSept Plus 15104

GUDID 20898021000109

Skin and would cleanser.

ANGELINI PHARMA INC.

Antimicrobial wound irrigation solution, non-sterile

• Primary Device ID: 20898021000109
• NIH Device Record Key: dc6998fe-8660-4a3c-98ad-68fe9fa13db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExSept Plus
• Version Model Number: 100 mL
• Catalog Number: 15104
• Company DUNS: 078843940
• Company Name: ANGELINI PHARMA 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store upright in original container.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sun light.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00898021000105 [Primary]
GS1	20898021000109 [Package]; Contains: 00898021000105; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082858

FDA Product Code

• FQH: Lavage, Jet

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-19
• Device Publish Date: 2016-08-29

On-Brand Devices [ExSept Plus]

• 20898021000109: Skin and would cleanser.
• 00898021000099: Skin and wound cleanser.
• 00898021000082: Skin and wound cleanser.
• 20898021000079: Skin and wound cleanser.