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Inflation bulb, valve and tubing assembly

FDA UDI

Class II (US FDA UDI)

by Omron Healthcare, Inc.

Identity

Trade Name
Inflation bulb, valve and tubing assembly FDA UDI
Generic Name
Blood pressure cuff inflator, manual FDA UDI
Model / Reference
0146GRAY FDA UDI

Identifiers

Primary DI / UDI-DI
00073796014667 FDA UDI
510(k) Number
K903133 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Blood pressure cuff inflator, manual 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 inflator, manual

Inflation bulb, valve and tubing assembly by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood pressure cuff inflator, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omron Healthcare, Inc.

Sources (1)

  • FDA UDI 4ad9ab7d-ca95-4791-996d-ee4a686e2348 34 fields · synced Jun 8, 2026