← Back to catalogue

Danlee Medical Kit

FDA UDI

by Danlee Medical Products, Inc.

Identity

Trade Name
DANLEE MEDICAL KIT FDA UDI
Generic Name
Electrocardiographic long-term ambulatory recording support kit FDA UDI
Device Name
ECG PREP KIT (ZKIT) CONMED FDA UDI
Model / Reference
NAVKIT9V FDA UDI
Description
ECG PREP KIT (ZKIT) CONMED FDA UDI

Identifiers

Primary DI / UDI-DI
00816310020733 FDA UDI
GMDN Term
Electrocardiographic long-term ambulatory recording support kit FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrocardiographic long-term ambulatory recording support kit

Danlee Medical Kit by Danlee Medical Products, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic long-term ambulatory recording support kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Danlee Medical Products, Inc.

Sources (1)

  • FDA UDI 25d09b91-3a19-4ba8-b6a0-597955d50d4c 34 fields · synced May 31, 2026