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Safeguard®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
SAFEGUARD® FDA UDI
Generic Name
Femoral artery compression system, manual, single-use FDA UDI
Model / Reference
10884450249137 FDA UDI

Identifiers

Primary DI / UDI-DI
10884450249137 FDA UDI
FDA Product Code
DXC FDA UDI
GMDN Term
Femoral artery compression system, manual, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 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

Yes

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: Femoral artery compression system, manual, single-use

A noninvasive, non-powered device for providing compression to the puncture site on a patient after femoral artery catheterization or brachial/ radial artery access. It is designed as an alternative to direct hand pressure and may be used in conjunction with dressings/haemostatic agents.

Similar devices

Also classified as Femoral artery compression system, manual, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI ff9f14cf-43b1-4ba8-853d-709ab46156ed 33 fields · synced Jul 12, 2026