HME HumidStar 2 Plus Luer-Lock

GUDID 04048675703853

Drägerwerk AG & Co. KGaA

Heat/moisture exchanger, single-use
Primary Device ID04048675703853
NIH Device Record Key7e95e7c3-9689-402d-9924-8359f1ef107f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHME HumidStar 2 Plus Luer-Lock
Version Model NumberMP05840
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048675703853 [Primary]

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

Devices Manufactured by Drägerwerk AG & Co. KGaA

04048675125525 - CLIC adapter2025-05-02
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

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