Identity
- Trade Name
- NIBP Cuff EUDAMEDFDA UDIRespArray NIBP cuff FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP Cuff EUDAMED
- Model / Reference
- Small Adult E8 EUDAMED02.57.225235 FDA UDISmall adult,20.5cm-28cm, reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413804586 EUDAMEDFDA UDI06944413839496 FDA UDI
- Basic UDI-DI
- 69444138NIBPCuffJ4 EUDAMED
- 510(k) Number
- K220308 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood pressure cuff, reusable
RespArray NIBP cuff by Edan Instruments, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Orbit-K — SUNTECH MEDICAL, INC. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Cleared under the same submission
K220308 also covers:
- RespArray — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
Sources (3)
- FDA UDI 662c8e9c-f996-42c2-bcb3-aa2b333c6700 33 fields · synced Jul 27, 2026
- FDA UDI 8841383e-c82a-4b4c-9e29-035f43859e24 32 fields · synced May 30, 2026
- EUDAMED e6a8de1a-babc-4819-ab49-b8b73b6c1f3c 61 fields · synced Jul 27, 2026