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Fantabstic Danlee Electrode Resting Tab (100 Per Pouch)

FDA UDI

Class II (US FDA UDI)

by Danlee Medical Products, Inc.

Identity

Trade Name
FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH) FDA UDI
Generic Name
Electrocardiographic electrode, single-use FDA UDI
Model / Reference
ED3000 FDA UDI

Identifiers

Primary DI / UDI-DI
00816310022997 FDA UDI
510(k) Number
K931457 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Electrocardiographic electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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 Conditional FDA UDI

Category: Electrocardiographic electrode, single-use

Fantabstic Danlee Electrode Resting Tab (100 Per Pouch) by Danlee Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Electrocardiographic electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Danlee Medical Products, Inc.

Sources (1)

  • FDA UDI 82d8f5a9-7fcc-4c05-a3eb-4b92177407fe 34 fields · synced May 31, 2026