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ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
ICU Medical FDA UDI
Generic Name
Neutral-pressure intravenous line needleless valve-connector FDA UDI
Device Name
Spinning Spiros™ Closed Male Luer, 10 units FDA UDI
Model / Reference
CH2000S-10 FDA UDI
Description
Spinning Spiros™ Closed Male Luer, 10 units FDA UDI

Identifiers

Catalog Number
CH2000S-10 FDA UDI
Primary DI / UDI-DI
00840619033910 FDA UDI
510(k) Number
K082806 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Neutral-pressure intravenous line needleless valve-connector 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

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

Category: Neutral-pressure intravenous line needleless valve-connector

ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neutral-pressure intravenous line needleless valve-connector.

Cleared under the same submission

K082806 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI f95a40be-199b-4eaf-a623-bbd01896cc89 36 fields · synced Jun 8, 2026