FDA.reportPublic FDA data

Piccolo Medical

Primary DI
00860002238500
Brand
Piccolo Medical
Company
Piccolo Medical, Inc.
Model
FGS-15-773
Catalog number
FGS-15-773
Device description
Nav+ Guidance Set (10-Pack)
Published
2026-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
NGTSaline, Vascular Access Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2
NGTSaline, Vascular Access FlushGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243484000PM2+ System and SmartPICC StyletPiccolo Medical, Inc.2025-05-29LJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002238500PrimaryGS10
00860002238593Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002238500008600022385008600022385000860002238500
00860002238593008600022385938600022385930860002238593

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter navigation system support kitA collection of noninvasive devices intended to assist use of a central venous catheter navigation system during electrocardiographic (ECG) supported guidance and positioning of a central venous catheter. The kit is dedicated to ECG-supported catheter navigation and typically includes system components (e.g., ECG leads, connectors) and other supportive devices (e.g., cable cover). The kit is intended to support the procedure which involves the catheter used as an intravascular electrode whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
116996235
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002238531Piccolo MedicalFGS-15-640FGS-15-6402025-11-07
00860002238586Piccolo MedicalFGS-15-852FGS-15-8522025-11-07
00860002238524Piccolo MedicalFGN-15-779FGN-15-7792025-11-19
00860002238517Piccolo MedicalFGN-15-634FGN-15-6342025-11-07
00860002238548Piccolo MedicalFGN-15-694FGN-15-6942025-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902225631ARROWTELEFLEX INCORPORATEDLJS2026-08-18
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00682686005403AMSafe SP 0.9% NaClMedxl IncNGT2026-07-29
10682686005295Praxiject SP 0.9% NaClMedxl IncNGT2026-07-29
10801902192025ARROWTELEFLEX INCORPORATEDLJS2026-07-29
10801902194364ARROWTELEFLEX INCORPORATEDLJS2026-07-29
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
10801902213188ARROWTELEFLEX INCORPORATEDLJS2026-07-23
10801902226171ARROWTELEFLEX INCORPORATEDLJS2026-07-06
00801741235207PowerPICCBard Access Systems, Inc.LJS2026-06-24
00801741235214PowerPICC ProvenaBard Access Systems, Inc.LJS2026-06-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
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
00860002238531Piccolo MedicalPiccolo Medical, Inc.LJS2025-11-07
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
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
10682686005288Praxiject™ SP 0.9% NaClMedxl IncNGT2024-07-25