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
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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 sterile, 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 Temperature10 Degrees Celsius38 Degrees Celsius

Regulatory Flags#

DUNS number
116996235
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H787MRC3S9110AngioDynamicsANGIODYNAMICS, INC.LJS2022-10-25
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H96560M0224770BioFloNAVILYST MEDICAL, INC.LJS2020-06-26