Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013226

FEI Number

3013226

Entity Name

NORMED

City/State/Country

SEATTLE, WA, US

Establishment Address

4320 SOUTH 131ST PL., Suite 160, SEATTLE, WA 98168, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NORMED (Owner Number: 3013226)

Owner / Operator Contact Address

4310 SOUTH 131ST PL., --, Seattle, WA 98168, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171961

PMA Number

N/A

All Registered Proprietary Names

MICROSHIELD HANDLE RING CUTTER SCISSORS TOURNIQUET ankle brace Splinter Aid splinter remover RESCUE BLANKET OXYGEN MASK CPR MASK WRISTPRO SCISSORS FORCEPS elbow brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	1992-07-29
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1992-07-29
FNS	Ring Cutter	General Hospital	Class 1	880.6200	1992-07-29
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2018-12-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-07-29
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	1992-07-29
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2018-12-14
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2018-12-14
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2018-12-14
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-06-08
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	1992-07-29
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2018-12-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	1992-07-29
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-12-14
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-12-14
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2020-11-25
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2018-12-14
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1992-07-29
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	1986-06-10
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2018-12-14
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2018-12-14
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1992-07-29
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-12-14
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2018-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORMED

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
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3015168527	Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, CN
3018762668	PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.	Tuzla Istanbul, TR
3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
1225492	NextPhase Medical Devices LLC	ROCHESTER, NH, US
3006547005	NINGBO BESMED MEDICAL EQUIPMENT CORP.	NINGBO Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013226. Last updated year: 2026. Please use registration number 3013226 when referencing this establishment in official correspondence.