american safety & first aid

FDA Device Registration & Listing · Osceola, IN, US · Registration 1836546

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
1836546
FEI Number
3003304148
Entity Name
american safety & first aid
City/State/Country
Osceola, IN, US
Establishment Address
1452 3rd street, Osceola, IN 46561, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
AMERICANSAFETY& FIRST AID (Owner Number: 10025592)
Owner / Operator Contact Address
1452 third street, Osceola, IN 46561, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

American Safety & First Aid American Safety & First Aid American Safety & First Aid American Safety & First Aid American Safety & First Aid American Safety & First Aid

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2013-12-16
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2022-08-22
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2013-12-16
FQM Bandage, Elastic General Hospital Class 1 880.5075 2008-04-23
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2013-12-16
HWB Extractor Orthopedic Class 1 888.4540 2022-01-18

Official Correspondent

JAMIE KOVACS BURKS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERICANSAFETY& FIRST AID
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
K880871 John Wagner Associates, Inc. GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER 1988-05-20
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3038131023 UNITED TECHNOLOGY VIETNAM COMPANY LIMITED Quang Ha Commune Quang Ninh, VN
3005360866 QEL DOMINICANA S.A. ESPERANZA Valverde, DO
3043106338 SHENZHEN SPONGE NEW MATERIAL CO. LTD Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836546. Last updated year: 2026. Please use registration number 1836546 when referencing this establishment in official correspondence.
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