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StatLock Pro

FDA UDI

Class I (US FDA UDI)

by Bard Access Systems, Inc.

Identity

Trade Name
StatLock Pro FDA UDI
Generic Name
Wearable percutaneous catheter/tube holder FDA UDI
Device Name
StatLock Pro BNS FDA UDI
Model / Reference
PGNS002 FDA UDI
Description
StatLock Pro BNS FDA UDI

Identifiers

Catalog Number
PGNS002 FDA UDI
Primary DI / UDI-DI
10801741163729 FDA UDI
FDA Product Code
KMK FDA UDI
GMDN Term
Wearable percutaneous catheter/tube holder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Wearable percutaneous catheter/tube holder

StatLock Pro by Bard Access Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable percutaneous catheter/tube holder.

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 07663b83-1838-4a92-929f-15393fba5ef9 35 fields · synced Jun 9, 2026