FDA UDI
In Commercial Distribution
🇺🇸 United States
COSMED
DI: 18052400180201
·
Model: Fitmate
·
C O S M E D SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COSMED
- Primary DI
- 18052400180201
- Version / Model
- Fitmate
- Company Name
- C O S M E D SRL
- Labeler DUNS
- 438896136
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 8b42046d-d1eb-4ce2-ad54-0e0bfa3574ee
Device Description
The device is intended for use in clinical and research application to measure oxygen uptake. Fitmate is designed for the measurement of Resting Metabolic Rate only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | Anesthesiology | 868.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46876 | Indirect calorimeter | An electrically-powered device primarily intended to measure oxygen consumption (VO2) and/or carbon dioxide output (VCO2) to estimate resting energy expenditure (REE) and/or resting metabolic rate (RMR), typically for weight loss/maintenance and nutritional assessments. It is intended to be used with a face mask, mouthpiece and/or head hood into which the patient breathes, and includes a display, controls, and connection ports. It is used in healthcare or research settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18052400180201 | GS1 |
Customer Contacts
- Phone
- +39069315492
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071533 | 000 |