FDA UDI
In Commercial Distribution
🇺🇸 United States
Metaphor Flow Sensor
DI: B23133141
·
Model: Neonate
·
TREYMED INC
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Metaphor Flow Sensor
- Primary DI
- B23133141
- Version / Model
- Neonate
- Catalog Number
- 3314
- Company Name
- TREYMED INC
- Labeler DUNS
- 078515394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-09-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 23ec0691-3b36-4652-a8b7-ccfa95d68d06
Device Description
Neonate flow sensor. Pack of 10.
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
- 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 |
|---|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | Anesthesiology | 868.1730 | 2 |
| BZC | Calculator, Pulmonary Function Data | Anesthesiology | 868.1880 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | Anesthesiology | 868.1700 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | Anesthesiology | 868.1720 | 2 |
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61834 | Breathing circuit gas-sampling/monitoring set | A collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B23133141 | HIBCC | ||||
| Unit of Use | B23133140 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093080 | 000 |