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Disposable Cuff

FDA UDI

Class II (US FDA UDI)

by Suntech Medical, Inc.

Identity

Trade Name
Disposable Cuff FDA UDI
Generic Name
Blood pressure cuff, reusable FDA UDI
Model / Reference
98-0800-70 FDA UDI

Identifiers

Primary DI / UDI-DI
10840935100744 FDA UDI
510(k) Number
K080854 FDA UDI
FDA Product Code
DXQ FDA UDI
GMDN Term
Blood pressure cuff, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1120 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

A reusable disposable cuff designed for blood pressure monitoring, ideal for use in a clinical setting or at home. This device features an inflatable bladder in an inelastic sleeve with one or two connecting tubes, allowing for effortless connection and inflation/deflation.

Cleared under the same submission

K080854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suntech Medical, Inc.

Sources (1)

  • FDA UDI 23f79e1f-78f8-4ef2-87b6-bff0699a9c47 35 fields · synced Jul 19, 2026