Chemosite 120049
GUDID 10884521099272
Catheter Introducer Kit
Covidien LP
Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable| Primary Device ID | 10884521099272 |
| NIH Device Record Key | d1aee95d-f9bb-442f-afd4-a7b61fd119a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chemosite |
| Version Model Number | 120049 |
| Catalog Number | 120049 |
| 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 | true |
| OTC Over-The-Counter | false |
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 | |
| 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 | |
| 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
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 0.035 Millimeter |
| Total Volume | 12 Milliliter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521099272 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K952748
FDA Product Code
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
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 | 2019-06-07 |
| Device Publish Date | 2015-10-22 |
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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