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Trinity Sterile, Inc.

FDA UDI

Class II (US FDA UDI)

by Trinity Sterile, Inc.

Identity

Trade Name
Trinity Sterile, Inc. FDA UDI
Generic Name
Tracheostomy care kit, single-use FDA UDI
Device Name
TRACH CARE W/GLOVES FDA UDI
Model / Reference
20104 FDA UDI
Description
TRACH CARE W/GLOVES FDA UDI

Identifiers

Primary DI / UDI-DI
10841767102869 FDA UDI
FDA Product Code
NXA FDA UDI
GMDN Term
Tracheostomy care kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Tracheostomy care kit, single-use

Trinity Sterile, Inc. by Trinity Sterile, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostomy care kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trinity Sterile, Inc.

Sources (1)

  • FDA UDI 68cb6219-0921-4d34-a153-cd5c248b9ebc 33 fields · synced Jun 8, 2026