spirette FA Pro/LAB

GUDID 07640142190646

NDD Medizintechnik AG

Pulmonary function testing filter/mouthpiece
Primary Device ID07640142190646
NIH Device Record Key51e9e756-a56b-4f0c-a9c0-77ba38451576
Commercial Distribution StatusIn Commercial Distribution
Brand Namespirette FA Pro/LAB
Version Model Number2050-73
Company DUNS487451916
Company NameNDD Medizintechnik AG
Device Count200
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com
Phone(877)9040090
Emailcustomerservice@nddmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142190646 [Unit of Use]
GS107640142190653 [Primary]
GS107640142190660 [Primary]
GS107640142190684 [Primary]

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

Devices Manufactured by NDD Medizintechnik AG

07640142190677 - spirette m2023-07-03
07640142190479 - Spiro-SP TrueFlow Sensor2023-07-03
07640142190646 - spirette FA Pro/LAB2023-07-03
07640142190646 - spirette FA Pro/LAB2023-07-03
07640142190486 - spirette2023-06-30
07640142190516 - EasyOne FlowTube2023-06-30
07640142190462 - EasyOne FlowTube2023-06-30
07640142190561 - Filter Adapter SP2023-06-30
07640142190578 - Filter Adapter FT2023-06-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.