Elite Stethoscope Not Applicable

GUDID 00816703023204

Elite Dual-Head Steth, Black, Elite First Aid Part Number: 601

MEDSOURCE INTERNATIONAL LLC

Mechanical stethoscope
Primary Device ID00816703023204
NIH Device Record Key5aeb7356-f8f4-4361-956a-15dfaa267daf
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite Stethoscope
Version Model NumberELITE-70031
Catalog NumberNot Applicable
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816703023198 [Primary]
GS100816703023204 [Package]
Contains: 00816703023198
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

LDEStethoscope, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-29
Device Publish Date2021-04-20

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

00840155401419 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 14Gx1.25
00840155406179 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 16Gx1.25
00840155413870 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1.25
00840155413900 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 22Gx1
00840155413931 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 24Gx0.75
00840155413962 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
00840155413993 - MedSource Winged Catheters2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
00840155414020 - MedSource Winged Catheters2023-10-16 ClearSafe Comfort I.V. Catheter, 16g x1.25 pur, winged

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