Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1034116

FEI Number

1034116

Entity Name

CARE LINE, INC.

City/State/Country

GREENBRIER, TN, US

Establishment Address

2210 LAKE RD., GREENBRIER, TN 37073, US

Establishment Type(s)

Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CARE LINE, INC. (Owner Number: 1034116)

Owner / Operator Contact Address

2210 LAKE RD, Greenbrier, TN 37073, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Care Line Care Line Care Line Care Line Care Line Care Line cold pack Care Line Care Line

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-07-24
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2016-02-23
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-02-23
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2016-02-23
FNP	Urinal	General Hospital	Class 1	880.6730	2016-02-23
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2016-02-23
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2015-12-14
FOB	Bedpan	General Hospital	Class 1	880.6730	2016-02-23
FQZ	Thermometer, Clinical Color Change	General Hospital	Class 1	880.2900	2019-07-01
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2016-02-23

Official Correspondent

JOHN LOVE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARE LINE, 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1034116. Last updated year: 2026. Please use registration number 1034116 when referencing this establishment in official correspondence.