ECG 3-Lead single pin AHA 1m

GUDID 04048675546870

Drägerwerk AG & Co. KGaA

Electrocardiographic lead set, reusable
Primary Device ID04048675546870
NIH Device Record Keyabbbe2ff-e01d-4a2d-b5d5-6fd9f848865c
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG 3-Lead single pin AHA 1m
Version Model Number2612001
Company DUNS315578914
Company NameDrägerwerk AG & Co. KGaA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675546870 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-18
Device Publish Date2025-04-10

Devices Manufactured by Drägerwerk AG & Co. KGaA

04048675379317 - ECG trunk cable,3-lead,Neo2025-04-18
04048675379324 - ECG limb wires, 3-lead, IEC2025-04-18
04048675379331 - ECG limb wires,5-lead,IEC2025-04-18
04048675379348 - ECG trunk cable,3-lead,IEC/AHA2025-04-18
04048675379355 - ECG trunk cable,5-lead,IEC/AHA2025-04-18
04048675379362 - ECG limb wires, 3-lead, AHA2025-04-18
04048675379379 - ECG Limb Wires, 5-lead, AHA2025-04-18
04048675546863 - ECG 3-Lead single pin IEC 1m2025-04-18

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.