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Bci

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
BCI FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Model / Reference
6124 FDA UDI

Identifiers

Primary DI / UDI-DI
15019517043082 FDA UDI
510(k) Number
K984618 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral vascular intervention infusion catheter

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

Similar devices

Also classified as Peripheral vascular intervention infusion catheter.

Cleared under the same submission

K984618 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 884ed477-040e-4667-bdf9-d25c226e3c57 33 fields · synced May 30, 2026