Identity
- Trade Name
- RespArray FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- REF:RPAYAHA01EFSBP FDA UDI
- Model / Reference
- 83.60.262672 FDA UDI
- Description
- REF:RPAYAHA01EFSBP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413831988 FDA UDI
- 510(k) Number
- K220308 FDA UDI
- FDA Product Code
- MHX FDA UDIDRT FDA UDIDXN FDA UDIDSK FDA UDIFLL FDA UDIDQA FDA UDICCK FDA UDIDSI FDA UDIMLD FDA UDIDSB FDA UDI
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2300 FDA UDI870.1130 FDA UDI870.1110 FDA UDI880.2910 FDA UDI870.2700 FDA UDI868.1400 FDA UDI870.2770 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
RespArray by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- SpO2 Adapter cable — Orantech Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
Cleared under the same submission
K220308 also covers:
- RespArray NIBP Cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP cuff — Edan Instruments, Inc.
- RespArray NIBP hose — Edan Instruments, Inc.
- RespArray Temperature probe — Edan Instruments, Inc.
- RespArray Temperature probe — Edan Instruments, Inc.
- RespArray Temperature probe — Edan Instruments, Inc.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
Sources (1)
- FDA UDI 9c6ac64b-9005-4379-80e4-faf3ed6f151c 34 fields · synced May 30, 2026