FDA.reportPublic FDA data

Chemosite

Primary DI
10884521099357
Brand
Chemosite
Company
Covidien LP
Model
120025
Catalog number
120025
Device description
Low Profile Venous Access System,120026;120039
Published
2015-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJSCatheter,intravascular,therapeutic,long-term greater than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961856000AUTO SUTURE CHEMOSITE TUNNELERUnited States Surgical, A Division of Tyco Healthc1996-07-18LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521099357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452109935710884521099357

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1Millimeter
Outer Diameter2.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902225631ARROWTELEFLEX INCORPORATEDLJS2026-08-18
10801902192025ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902194364ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
00801741240034PowerPICC SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240041PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240058PowerPICC Provena SOLOBard Access Systems, Inc.LJS2026-05-27
00801741240065PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00801741240072PowerPICC Provena SOLO Catheter with Sherlock 3CGBard Access Systems, Inc.LJS2026-05-27
00860002238500Piccolo MedicalPiccolo Medical, Inc.LJS2026-05-06
00884908185386Vascu-PICC®Medical Components, Inc.LJS2025-11-20
00860002238531Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
00860002238586Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
10192253040241ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040258ArgyleCardinal Health 200, LLCLJS2025-01-08
10192253040265ArgyleCardinal Health 200, LLCLJS2025-01-08
20801902198086ARROWTELEFLEX INCORPORATEDLJS2022-12-01
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