FDA UDI
In Commercial Distribution
🇺🇸 United States
COSMED
DI: 18052400180171
·
Model: Quark RMR
·
C O S M E D SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COSMED
- Primary DI
- 18052400180171
- Version / Model
- Quark RMR
- 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
- e36794c4-74ec-46c9-91c9-31cf073bf98b
Device Description
The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.
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 |
|---|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | Anesthesiology | 868.1890 | 2 |
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 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 | 18052400180171 | GS1 |
Customer Contacts
- Phone
- +39069315492
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120146 | 000 |