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AccuFlo

FDA UDI

Class II (US FDA UDI)

by EMED Technologies Corporation

Identity

Trade Name
AccuFlo FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
92" IV Set w/ IV Flow Regulator FDA UDI
Model / Reference
FLO-100 FDA UDI
Description
92" IV Set w/ IV Flow Regulator FDA UDI

Identifiers

Catalog Number
FLO-100 FDA UDI
Primary DI / UDI-DI
00817708020229 FDA UDI
510(k) Number
K935642 FDA UDI
FDA Product Code
FPK FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

Yes

FDA UDI

Category: Basic intravenous administration set, noninvasive

AccuFlo by EMED Technologies Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Cleared under the same submission

K935642 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EMED Technologies Corporation

Sources (1)

  • FDA UDI 7e5ba38b-8cf1-4c4e-8228-c72e4594b807 37 fields · synced Jun 9, 2026