FDA Registration
Active
🇺🇸 United States
CARE LINE, INC.
Reg #: 1034116
·
FEI: 1034116
·
Expires 2026
Products
15
Proprietary Names
3
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- CARE LINE, INC.
- Registration Number
- 1034116
- FEI Number
- 1034116
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2210 LAKE RD.
- City
- GREENBRIER
- State
- TN
- ZIP
- 37073
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110776
Owner / Operator
- Firm Name
- CARE LINE, INC.
- Operator Number
- 1034116
- Address
- 2210 LAKE RD
- City
- Greenbrier
- State
- TN
- Postal Code
- 37073
- Country
- US
- Correspondent
- JOHN D LOVE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-07-24 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2016-02-23 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2016-02-23 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2016-02-23 |
| Urinal | FNP | Class 1 | General Hospital | No | 2016-02-23 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2016-02-23 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2015-12-14 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2016-02-23 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2019-07-01 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2016-02-23 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2016-02-23 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2013-08-28 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-11-20 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2002-02-25 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2005-12-28 |
Proprietary Names
Care Line
Care Line cold pack
GENERIC
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)