FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FloSense
DI: B279298020K1
·
Model: Klip BiDirectional
·
S D I DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- FloSense
- Primary DI
- B279298020K1
- Version / Model
- Klip BiDirectional
- Catalog Number
- 298020K
- Company Name
- S D I DIAGNOSTICS INC
- Labeler DUNS
- 037690120
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2017-02-11
- Public Version
- 4
- Public Version Date
- 2019-08-26
- Public Version Status
- Update
- Public Device Record Key
- 8e449f21-55d8-4bf6-a852-f675416d6da6
- Distribution End Date
- 2019-08-23
Device Description
Pneumotachometer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JAX | Pneumotachometer | Anesthesiology | 868.2550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35282 | Pulmonary function analysis system, adult | A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B279298020K1 | HIBCC | ||||
| Unit of Use | B279298020K11 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990962 | 000 |