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Custom Medical Specialties, Inc.

FDA UDI

Class II (US FDA UDI)

by Custom Assemblies, Inc.

Identity

Trade Name
Custom Medical Specialties, Inc. FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
60" Straight Injection Line - Sterile FDA UDI
Model / Reference
CMS-155 FDA UDI
Description
60" Straight Injection Line - Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00815849021372 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

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: Basic intravenous administration set, noninvasive

Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Custom Assemblies, Inc.

Sources (1)

  • FDA UDI ae1bd5d6-26ef-4139-b152-3b7531002336 33 fields · synced Jun 8, 2026