CODMAN® BACTISEAL® 82-3088
GUDID 10381780537045
BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit MR Conditional Contents: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adapter (1)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Intracerebral infusion/drainage catheter, short-term| Primary Device ID | 10381780537045 |
| NIH Device Record Key | 9d375f0d-68a7-4576-9aaa-749d94cfeb7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CODMAN® BACTISEAL® |
| Version Model Number | 823088 |
| Catalog Number | 82-3088 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
| Catheter Length | 14 Centimeter |
| Catheter Length | 120 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780537045 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233445
FDA Product Code
| HCA | CATHETER, VENTRICULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-28 |
| Device Publish Date | 2024-11-20 |
On-Brand Devices [CODMAN® BACTISEAL®]
| 10381780537151 | CODMAN® BACTISEAL® Ventricular Catheter with Centimeter Markings with BACTISEAL Shunt System M |
| 10381780537137 | CODMAN® BACTISEAL® 23cm Ventricular Catheter Set MR Conditional Contents: Ventricular Catheter |
| 10381780537120 | CODMAN® BACTISEAL® Catheters MR Conditional Contents: Ventricular Catheter 15cm (1), Right Ang |
| 10381780537113 | CODMAN® BACTISEAL® Catheter MR Conditional Contents: Peritoneal Catheter 120cm (1) |
| 10381780537106 | CODMAN® BACTISEAL® Large Ventricular Catheter MR Conditional Contents: Ventricular Catheter 15 |
| 10381780537083 | CODMAN® BACTISEAL® 23cm Ventricular Catheter MR Conditional Contents: Ventricular Catheter 23c |
| 10381780537076 | CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit MR Conditional Contents: Ventricular |
| 10381780537069 | CODMAN® BACTISEAL® Clear with Barium Stripe Distal Catheter 120cm MR Conditional Contents: Dis |
| 10381780537052 | CODMAN® BACTISEAL® Clear with Barium Stripe Ventricular Catheter 15cm MR Conditional Contents: |
| 10381780537045 | BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit MR Conditional Cont |
| 10381780537038 | BEVC BACTISEAL® Endoscopic Ventricular Catheter MR Conditional Contents: Ventricular Catheter 1 |
| 10381780537021 | CODMAN® BACTISEAL® Clear Catheter 1.9mm I.D. Catheter Set MR SAFE Contents:35cm Ventricular Ca |
| 10381780537014 | CODMAN® EVD BACTISEAL® 1.9mm I.D. Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1) |
| 10381780537007 | CODMAN® BACTISEAL® Distal Catheter Kit with BACTISEAL Shunt System MR CONDITIONAL Contents: Di |
| 10381780536994 | CODMAN® BACTISEAL® Ventricular Catheter with BACTISEAL Shunt System MR CONDITIONAL Contents: V |
| 10381780536987 | CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with BACTISEAL Shunt System MR |
| 10381780536970 | CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1) |
| 10381780525370 | CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1) |
| 10381780524106 | CODMAN® BACTISEAL® 1.5mm I.D. EVD Catheter Set MR SAFE Contents: 20cm Ventricular Catheter (1) |
Trademark Results [CODMAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODMAN 72381672 0917323 Live/Registered |
JOHNSON & JOHNSON 1971-02-18 |
 CODMAN 72381347 0925169 Live/Registered |
JOHNSON & JOHNSON 1971-02-11 |
 CODMAN 72258343 0840934 Live/Registered |
CODMAN & SHURTLEFF, INC. 1966-11-10 |
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