INTERA AP07004
GUDID 00850014110154
Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
INTERA ONCOLOGY INC.
Hypodermic needle, single-use| Primary Device ID | 00850014110154 |
| NIH Device Record Key | f0851b79-7387-4927-945a-2a4cc655e004 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTERA |
| Version Model Number | AP-07004 |
| Catalog Number | AP07004 |
| Company DUNS | 117070072 |
| Company Name | INTERA ONCOLOGY 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if opened or damaged |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850014110154 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| LKK | Pump, Infusion, Implanted, Programmable |
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 | 2021-08-05 |
| Device Publish Date | 2021-07-28 |
On-Brand Devices [INTERA]
| 10850014110052 | Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 2" (5 |
| 10850014110021 | Non-coring (Huber) needle for use with Intera 3000 Hepatic Artery Infusion Pump, Straight, 22 Ga |
| 00850014110093 | Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Conn |
| 00850014110154 | Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) S |
| 00850014110147 | Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit |
| 00850014110079 | Refill Kit - Intera 3000 |
| 10850014110045 | Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8 |
| 00850014110130 | Intera 3000 Implantable Pump Operating Room Prep Kit |
| 10850014110038 | Non-coring (Huber) needle for use with Intera Infusion Pumps, Straight, 22 Gauge, 2 inch |
| 10850014110014 | Non-coring (Huber) needle for use with Intera Infusion Pumps, Straight, 22 Gauge, 1 inch |
Trademark Results [INTERA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERA 98373021 not registered Live/Pending |
INTERA Incorporated 2024-01-24 |
 INTERA 90167542 not registered Live/Pending |
Bao,Mei 2020-09-09 |
 INTERA 90154194 not registered Live/Pending |
Bao,Mei 2020-09-02 |
 INTERA 88638443 not registered Live/Pending |
Creatick 2019-10-01 |
 INTERA 86924533 not registered Dead/Abandoned |
Shandy, Matthew 2016-03-01 |
 INTERA 86061145 4857508 Live/Registered |
Rethink Robotics, Inc. 2013-09-10 |
 INTERA 85371390 not registered Dead/Abandoned |
Skyworks Solutions, Inc. 2011-07-14 |
 INTERA 78617309 not registered Dead/Abandoned |
SKYWORKS SOLUTIONS, INC. 2005-04-26 |
 INTERA 78615264 not registered Dead/Abandoned |
SKYWORKS SOLUTIONS, INC. 2005-04-22 |
 INTERA 78212097 2987166 Dead/Cancelled |
INTERA TECHNOLOGIES, INC. 2003-02-07 |
 INTERA 77022992 not registered Dead/Abandoned |
Intermetal, LTD 2006-10-17 |
 INTERA 76691732 not registered Dead/Abandoned |
MAXXMAR Inc 2008-07-31 |
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