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Cultura™

FDA UDI

Class I (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Cultura™ FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection swab FDA UDI
Model / Reference
00884450495834 FDA UDI

Identifiers

Catalog Number
C100F/A FDA UDI
Primary DI / UDI-DI
00884450495834 FDA UDI
FDA Product Code
KXG FDA UDI
GMDN Term
Oral/upper respiratory tract specimen collection swab FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6025 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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Oral/upper respiratory tract specimen collection swab

Cultura™ by Merit Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/upper respiratory tract specimen collection swab.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 39e743ff-f586-428b-8265-764538aba845 33 fields · synced Jun 9, 2026