FDA UDI
In Commercial Distribution
🇺🇸 United States
FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit
DI: 00709078004414
·
Model: 9571
·
WESTMED, INC.
Product Codes
3
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit
- Primary DI
- 00709078004414
- Version / Model
- 9571
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-07
- Public Version
- 4
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 4530c0de-fa8e-4063-8cad-6cec06524fcc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Anesthesiology | 868.5240 | 1 |
| OGL | Oxygen Administration Kit | Anesthesiology | 868.5655 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37616 | Stationary angiographic x-ray system, analogue | A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses analogue or analogue-to-digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats. | No | Active |
| 46816 | Heat/moisture exchanger/microbial medical gas filter | A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078004411 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00709078004414 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922492 | 000 |