FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FloSense II
DI: B279DP300050
·
Model: FloSense II
·
S D I DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- FloSense II
- Primary DI
- B279DP300050
- Version / Model
- FloSense II
- Catalog Number
- DP300-050
- Company Name
- S D I DIAGNOSTICS INC
- Labeler DUNS
- 037690120
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 6
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- bf3829b6-f3bd-4071-8689-209fedadb8af
- Distribution End Date
- 2022-12-06
Device Description
FloSense II Sensor
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| BZG | Spirometer, Diagnostic | Anesthesiology | 868.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44545 | Breathing mouthpiece, single-use | A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B279DP300200 | HIBCC | case | 50 | Not in Commercial Distribution | 2022-12-06 |
| Primary | B279DP300050 | HIBCC | ||||
| Unit of Use | DP3000501 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033939 | 000 |