Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058397

FEI Number

1000158532

Entity Name

NEIL MEDICAL GROUP

City/State/Country

Kinston, NC, US

Establishment Address

2545 Jetport Rd, Kinston, NC 28504, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Neil Medical Group (Owner Number: 10090834)

Owner / Operator Contact Address

2545 Jetport Rd, Kinston, NC 28504, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121526

PMA Number

N/A

All Registered Proprietary Names

Manual Wheelchair ENTERAL DELIVERY GRAVITY BAG W/ ENFIT Isolation Mask Exam Grade Blue Nitrile Pulse Qximeter Exam Grade Yellow Stretch Vinyl Gloves PRE-FILLED SYRINGE URINARY LEG BAG URETHRAL CATH TRAY 14FR PVC CATH Exam Grade Blue Nitrile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2025-07-16
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2025-12-04
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-12-04
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-06-17
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-04-03
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-06-06
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-07-02
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-12-04
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-12-04
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2025-12-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-05-20

Official Correspondent

Glenn Espiritu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neil Medical Group

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
K935211	Brookefield Hunter, Inc.	WALK N CHAIR	1994-02-02
K832685	Health America	WHEELCHAIR-VARIOUS MODELS	1983-09-20
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058397. Last updated year: 2026. Please use registration number 1058397 when referencing this establishment in official correspondence.