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Site~Rite 8

FDA UDI

Class II (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
Site~Rite 8 FDA UDI
Generic Name
Central venous catheter navigation system, electrocardiographic/magnetic FDA UDI
Device Name
Site~Rite 8 Sherlock Application Software FDA UDI
Model / Reference
Sherlockv3.1.1 FDA UDI
Description
Site~Rite 8 Sherlock Application Software FDA UDI

Identifiers

Catalog Number
Sherlockv3.1.1 FDA UDI
Primary DI / UDI-DI
00801741219436 FDA UDI
FDA Product Code
LJS FDA UDI
GMDN Term
Central venous catheter navigation system, electrocardiographic/magnetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5970 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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheter navigation system, electrocardiographic/magnetic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bard Access Systems, Inc.

Sources (1)

  • FDA UDI d9971cfb-379c-4318-918f-1bfc37f4aa51 35 fields · synced Jun 9, 2026