Identity
- Trade Name
- MADA MEDICAL PRODUCTS, INC. FDA UDI
- Generic Name
- Anaesthesia/respiratory gas flowmeter tester FDA UDI
- Device Name
- A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. FDA UDI
- Model / Reference
- 1701-1 FDA UDI
- Description
- A device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. FDA UDI
Identifiers
- Catalog Number
- 1701-1 FDA UDI
- Primary DI / UDI-DI
- 00815160021228 FDA UDI
- FDA Product Code
- CAX FDA UDI
- GMDN Term
- Anaesthesia/respiratory gas flowmeter tester FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia/respiratory gas flowmeter tester
Mada Medical Products, Inc. by Mada Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia/respiratory gas flowmeter tester.
- Responsive Respiratory, Inc. — RESPONSIVE RESPIRATORY INC. · Class I
- Flow Analyzer PF-300 PRO — IMT ANALYTICS INC. · Class I
- Flow Analyzer PF-300 — IMT ANALYTICS INC. · Class I
- Responsive Respiratory, Inc. — RESPONSIVE RESPIRATORY INC. · Class I
- MicroMax Blender Buddy — Maxtec, Inc. · Class I
- CITREX H4 — IMT ANALYTICS INC. · Class I
- FlowMeter F1 — IMT ANALYTICS INC. · Class I
- MAXBLEND 2 — Maxtec, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mada Medical Products, Inc.
Sources (1)
- FDA UDI 7d892131-2e1a-4dee-b372-c68742be0000 34 fields · synced May 30, 2026