ExSept Plus 15117
GUDID 20898021000079
Skin and wound cleanser.
ANGELINI PHARMA INC.
Antimicrobial wound irrigation solution, non-sterile| Primary Device ID | 20898021000079 |
| NIH Device Record Key | a8001e7b-3f39-43c9-a4e9-2250e6b28322 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ExSept Plus |
| Version Model Number | 500 mL |
| Catalog Number | 15117 |
| 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 |
Customer Support Contacts
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 | 00898021000075 [Primary] |
| GS1 | 20898021000079 [Package] Contains: 00898021000075 Package: case [12 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. |
Trademark Results [ExSept Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXSEPT PLUS 76548473 2874115 Live/Registered |
ANGELINI PHARMA INC. 2003-10-02 |
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