D-Stat

FDA UDI

Class U (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: D-STAT FDA UDI
Generic Name: Radial artery compression device FDA UDI
Device Name: Dstat RadBand FDA UDI
Model / Reference: IPN913637 FDA UDI
Description: Dstat RadBand FDA UDI

Identifiers

Catalog Number: 3501R FDA UDI
Primary DI / UDI-DI: 10841156101749 FDA UDI
FDA Product Code: QSX FDA UDI
GMDN Term: Radial artery compression device 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radial artery compression device

D-Stat by Teleflex Incorporated — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radial artery compression device.

PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
Cordis Zephyr Vascular Compression Band — Semler Technologies, Inc. · Class II
MEDADV — MEDAS, INC. · Class II
HemCon® ChitoPulse™, 15 inch — Tricol Biomedical, INC. · Class II
PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
TRAcelet™ — MEDTRONIC, INC. · Class II
PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI ae7b20f2-34ac-4509-94e5-9dce83d91190 35 fields · synced May 31, 2026