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Spectrum, Inc.

FDA UDI

Class U (US FDA UDI)

by Spectrum Co.

Identity

Trade Name
Spectrum, Inc. FDA UDI
Generic Name
General specimen container IVD, no additive, sterile FDA UDI
Device Name
Specimin Container, 32 Oz, Sterile FDA UDI
Model / Reference
987-03923-000 FDA UDI
Description
Specimin Container, 32 Oz, Sterile FDA UDI

Identifiers

Catalog Number
725100 FDA UDI
Primary DI / UDI-DI
00850301007792 FDA UDI
510(k) Number
K863872 FDA UDI
FDA Product Code
LPZ FDA UDI
GMDN Term
General specimen container IVD, no additive, sterile FDA UDI

Classification

Device Class
U 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Safe FDA UDI

Category: General specimen container IVD, no additive, sterile

Spectrum, Inc. by Spectrum Co. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive, sterile.

Cleared under the same submission

K863872 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Co.

Sources (1)

  • FDA UDI 22b1bda2-9e4b-4ef8-9b84-f06798e1c90e 36 fields · synced Jun 8, 2026