FlashPad

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems, Inc.

Identity

Trade Name: FlashPad FDA UDI
Generic Name: Vascular dilator, single-use FDA UDI
Model / Reference: 5340000-7 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682116732 FDA UDI
510(k) Number: K102615 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Vascular dilator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular dilator, single-use

FlashPad by Ge Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular dilator, single-use.

Prelude® — Merit Medical Systems, Inc. · Class II
Micro ACE™ — Merit Medical Systems, Inc. · Class II
Prelude ACT™ — Merit Medical Systems, Inc. · Class II
Prelude® — Merit Medical Systems, Inc. · Class II
Prelude EASE™ — Merit Medical Systems, Inc. · Class II
Prelude PRO™ — Merit Medical Systems, Inc. · Class II
Merit MAK™ — Merit Medical Systems, Inc. · Class II
Merit PAK™ — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K102615 also covers:

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ge Medical Systems, Inc.

Sources (1)

FDA UDI bbe03d5f-e328-4d84-b72a-9c6f6b7f4026 33 fields · synced May 30, 2026