Identity
- Trade Name
- E-Sphyg™ II FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Battery Pack Cover ONLY-9002, FDA UDI
- Model / Reference
- 9002-4 FDA UDI
- Description
- Battery Pack Cover ONLY-9002, FDA UDI
Identifiers
- Catalog Number
- 9002-4 FDA UDI
- Primary DI / UDI-DI
- 00634782057886 FDA UDI
- 510(k) Number
- K061086 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
E-Sphyg™ II by American Diagnostic Corporation — Class II — FDA UDI — listed in FDA GUDID — 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
K061086 also covers:
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
- E-Sphyg™ II — American Diagnostic Corporation
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
- American Diagnostic Corporation
Sources (1)
- FDA UDI 16c468fc-7640-4ec8-a962-c7a95692e627 37 fields · synced May 30, 2026