SAM MEDICAL PRODUCTS

FDA Device Registration & Listing · Tualatin, OR, US · Registration 3023316

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023316
FEI Number
3023316
Entity Name
SAM MEDICAL PRODUCTS
City/State/Country
Tualatin, OR, US
Establishment Address
12200 Sw Tualatin Rd Ste 200, Tualatin, OR 97062, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SAM Medical Products (Owner Number: 3023316)
Owner / Operator Contact Address
12200 SW Tualatin Road, Suite 200, Tualatin, OR 97062, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SAM IO SAM IO Intraosseous Access System; SAM IO SAM Chest Seal with Valve SAM Chest Seal SAM Chest Seal Combo SAM Chest Seal Valved 2 SAM ThoraSite SAM Pelvic Sling II (SM, ST, LG, OD) Chito-SAM Active Chito-SAM 100 DART; PneumoDart; TPAK 10, TPAK SAM IO Stabilizer SAM XT; SAM XT Extremity Tourniquet; SAM Extremity Tourniquet SAM Bleeding Control Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-11-17
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2020-02-14
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2011-03-21
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2021-01-19
IPW Orthosis, Sacroiliac, Soft Physical Medicine Class 1 890.3490 2003-12-03
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2015-02-26
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2025-12-11
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2020-04-30
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2017-02-17
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2018-06-13

Official Correspondent

Siri Belur

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAM Medical Products
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K220566 Koag, LLC Vascette HP (hemostatic pad) 2022-07-29
K080818 Hem Con Medical Technologies, Inc. HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING 2008-05-15
K893123 Les Laboratorires Brothier, S.A. ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES 1990-02-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023316. Last updated year: 2026. Please use registration number 3023316 when referencing this establishment in official correspondence.
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