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Novaplus

FDA UDI

Class II (US FDA UDI)

by O&M Halyard, Inc.

Identity

Trade Name
NOVAPLUS FDA UDI
Generic Name
Evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
Device Name
Novaplus ASTM Fluid-Rated Fog-Free Surgical Mask, Aqua FDA UDI
Model / Reference
47587 FDA UDI
Description
Novaplus ASTM Fluid-Rated Fog-Free Surgical Mask, Aqua FDA UDI

Identifiers

Catalog Number
47587 FDA UDI
Primary DI / UDI-DI
20680651475873 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Evacuated blood collection tube IVD, anticoagulant/separator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Evacuated blood collection tube IVD, anticoagulant/separator

Novaplus by O&M Halyard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evacuated blood collection tube IVD, anticoagulant/separator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O&M Halyard, Inc.

Sources (1)

  • FDA UDI 42d7cc90-ef1a-40bb-b0ff-f42c27b317ef 35 fields · synced May 30, 2026