FDA UDI
In Commercial Distribution
🇺🇸 United States
Flow sensor
DI: 04036616001809
·
Model: SpiroQuant A+
·
EnviteC-Wismar GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Flow sensor
- Primary DI
- 04036616001809
- Version / Model
- SpiroQuant A+
- Catalog Number
- 1000470
- Company Name
- EnviteC-Wismar GmbH
- Labeler DUNS
- 330943838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b997ae32-d4b2-4beb-a925-848dfe126040
Device Description
Flow sensor SpiroQuant A+
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BXP | Transducer, Gas Flow | Anesthesiology | 868.2885 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36849 | Breathing circuit gas-flow sensor, reusable | A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04036616001809 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 40 | Millimeter | |
| Length | 110 | Millimeter | |
| Width | 140 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius