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Early Bird Bleed Monitoring System

FDA UDI

Class II (US FDA UDI)

by Saranas, Inc.

Identity

Trade Name
Early Bird Bleed Monitoring System FDA UDI
Generic Name
Femoral artery/vein access catheter FDA UDI
Model / Reference
FG001-02 FDA UDI

Identifiers

Primary DI / UDI-DI
00866532000419 FDA UDI
510(k) Number
DEN180021 FDA UDI
FDA Product Code
QFJ FDA UDI
GMDN Term
Femoral artery/vein access catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1345 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Femoral artery/vein access catheter

Early Bird Bleed Monitoring System by Saranas, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral artery/vein access catheter.

Cleared under the same submission

DEN180021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Saranas, Inc.

Sources (1)

  • FDA UDI b82b12aa-0f79-4dd2-8c0e-506680794a4b 35 fields · synced Jun 1, 2026