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Trulink

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Trulink FDA UDI
Generic Name
Blood pressure cuff, reusable FDA UDI
Device Name
NIBP,HOSE,NEO.,QUICK RELEASE FDA UDI
Model / Reference
NIBP Hoses and adapters FDA UDI
Description
NIBP,HOSE,NEO.,QUICK RELEASE FDA UDI

Identifiers

Catalog Number
714-0019-01 FDA UDI
Primary DI / UDI-DI
10841522125942 FDA UDI
510(k) Number
K103142 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
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

Trulink by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K103142 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 9e47d2e4-3ae1-435e-a2a4-771c5a122c3b 37 fields · synced Jun 6, 2026