Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019804885

FEI Number

3019804885

Entity Name

Sargas LLC/ Sabik LLC/ Karaka LLC/Archernar LLC

City/State/Country

Chicago, IL, US

Establishment Address

444 W. Lake St, Suite 1700, Chicago, IL 60606, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

HYDY, Inc. (Owner Number: 10082377)

Owner / Operator Contact Address

444 W. Lake St, Suite 1700, Chicago, IL 60606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Swiss Safe Bandage Boka Stainless Steel Tongue Scraper Boka Classic Toothbrush Boka Brush 2 Surviveware Alcohol Pad Swiss Safe Alcohol Pad Boka Power Flosser Swiss Safe First Aid Kit Boka Floss Swiss Safe Gauze Swiss Safe Instant Cold Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-09-06
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2023-09-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-09-05
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-09-05
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2023-09-06
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2023-09-05
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2023-09-05
JES	Floss, Dental	Dental	Class 1	872.6390	2023-09-05
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-09-05
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2023-09-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HYDY, Inc.

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
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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019804885. Last updated year: 2026. Please use registration number 3019804885 when referencing this establishment in official correspondence.