Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004756837

FEI Number

3004756837

Entity Name

PENTAFERTE ITALIA S.R.L.

City/State/Country

CAMPLI Teramo, IT

Establishment Address

Viale Piane Nocella, 23, CAMPLI Teramo 64012, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PENTAFERTE ITALIA s.r.l. (Owner Number: 10057694)

Owner / Operator Contact Address

Viale Piane Nocella, 23, CAMPLI, IT-TE 64012, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161141

PMA Number

N/A

All Registered Proprietary Names

Pentaflush NUTRIFIT CRN CRONO SYRINGE RESERVOIR Nutrifit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGT	Saline, Vascular Access Flush	General Hospital	Class 2	880.5200	2023-12-07
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-06-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-05-15
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2018-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

Luca Giustini Email: l.giustini@pqegroup.com Phone: (267) 7958865

Related Public Records

Same Entity

PENTAFERTE ITALIA s.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2011	Excelsior Medical Corp	2	Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
Z-0044-2007	Excelsior Medical Corp	2	0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

Registration Number	Establishment Name	Location
3043709866	HANTECH (NINGBO) MEDICAL TECHNOLOGY CO., LTD.	Ningbo Zhejiang, CN
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3014421917	O&M Halyard, Inc.	Alpharetta, GA, US
3016413378	JIAXING TIANHE PHARMACEUTICAL CO., LTD.	Jiaxing Zhejiang, CN
3005934752	MEDXL INC	Pointe-Claire Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004756837. Last updated year: 2026. Please use registration number 3004756837 when referencing this establishment in official correspondence.