Identity
- Trade Name
- 1.3 Meter Air Tube Asssembly for HEM-907XL FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Air Tube for Blood Pressure Monitor HEM-907XL FDA UDI
- Model / Reference
- HEM-TUBE-130XL FDA UDI
- Description
- Air Tube for Blood Pressure Monitor HEM-907XL FDA UDI
Identifiers
- Catalog Number
- HEM-TUBE-130XL FDA UDI
- Primary DI / UDI-DI
- 00073796130428 FDA UDI
- 510(k) Number
- K032305 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
1.3 Meter Air Tube Asssembly for HEM-907XL by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood pressure cuff, reusable.
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- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- MDF® — MDF Instruments Medifriend Inc. · Class II
- Disposable Cuff — SUNTECH MEDICAL, INC. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Sklar® — Sklar Corporation · Class II
Cleared under the same submission
K032305 also covers:
- AC Adapter for HEM-907XL — Omron Healthcare, Inc.
- Battery Pack for HEM-907 and HEM-907XL — Omron Healthcare, Inc.
- Digital Blood Pressure Monitor — Omron Healthcare, Inc.
- Extra Large Cuff Assembly for HEM-907XL — Omron Healthcare, Inc.
- Large Cuff, Bladder for Hem-907 — Omron Healthcare, Inc.
- Medium Cuff, Bladder for HEM-907 — Omron Healthcare, Inc.
- Small Cuff, Bladder for Hem-907 — Omron Healthcare, 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 |
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Manufacturer
- Manufacturer
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI 6d863bd8-3c49-408e-aa6e-501393be6ba8 36 fields · synced May 31, 2026