Chemosite 120021
GUDID 10884521099371
Low Profile Venous Access System
Covidien LP
Subcutaneous infusion/injection port needle| Primary Device ID | 10884521099371 |
| NIH Device Record Key | 18caf93c-ea61-4c3a-b996-b0676972fed6 |
| Commercial Distribution Discontinuation | 2020-11-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Chemosite |
| Version Model Number | 120021 |
| Catalog Number | 120021 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
| Outer Diameter | 2.5 Millimeter |
| Outer Diameter | 1.3 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521099371 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K961856
FDA Product Code
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-05-17 |
| Device Publish Date | 2015-08-28 |
On-Brand Devices [Chemosite]
| 10884521099265 | Low Profile Venous Access System |
| 10884521099289 | Catheter Introducer Kit |
| 10884521099272 | Catheter Introducer Kit |
| 20884521099019 | Line Extension Set |
| 10884521176065 | Venous Access System |
| 20884521099194 | Straight Needle |
| 20884521099187 | Straight Needle |
| 20884521099170 | Straight Needle |
| 20884521099163 | Right Angle Needle |
| 20884521099156 | Right Angle Needle |
| 20884521099149 | Right Angle Needle |
| 20884521099132 | Right Angle Needle |
| 20884521099101 | Right Angle Needle |
| 20884521099071 | Line Extension Set |
| 20884521099064 | Line Extension Set,120075 |
| 20884521099057 | Line Extension Set |
| 20884521099040 | Line Extension Set |
| 20884521099033 | Line Extension Set |
| 20884521099026 | Line Extension Set |
| 20884521099002 | Line Extension Set |
| 20884521098999 | Line Extension Set |
| 10884521099401 | Low Profile Venous Access System |
| 10884521099395 | Low Profile Venous Access System |
| 10884521099388 | Low Profile Venous Access System |
| 10884521099371 | Low Profile Venous Access System |
| 10884521099364 | Low Profile Venous Access System,120027;120089 |
| 10884521099357 | Low Profile Venous Access System,120026;120039 |
| 10884521099340 | Low Profile Venous Access System |
| 10884521099333 | Venous Access System |
| 10884521099326 | Venous Access System,120039;120044 |
| 10884521099319 | Venous Access System |
| 10884521099302 | Venous Access System,120085;120089 |
| 10884521099296 | Venous Access System,120020;120039 |
| 10884521099258 | Low Profile Venous Access System |
| 10884521099241 | Venous Access System |
| 10884521099234 | Venous Access System |
| 10884521099203 | Venous Access System |
| 20884521099224 | Tunneler |
Trademark Results [Chemosite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHEMOSITE 75173830 2091327 Live/Registered |
COVIDIEN LP 1996-09-30 |
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