3982

GUDID 03596010121196

LEVELERT SENSOR W/CORD

Smith & Nephew, Inc.

Infusion controller, line-powered
Primary Device ID03596010121196
NIH Device Record Key93919f71-b367-4d9d-8193-c916091eda2f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3982
Catalog Number3982
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010121196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLNMONITOR, ELECTRIC FOR GRAVITY FLOW INFUSION SYSTEMS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

00885556901915 - EVOS2025-05-29 EVOS PELVIC 2.7MM X 16MM CORTEX SCREW BLUNT TIP
00885556901922 - EVOS2025-05-29 EVOS PELVIC 2.7MM X 18MM CORTEX SCREW BLUNT TIP
00885556901939 - EVOS2025-05-29 EVOS PELVIC 2.7MM X 20MM CORTEX SCREW BLUNT TIP
00885556901953 - EVOS2025-05-29 EVOS PELVIC 2.7MM X 24MM CORTEX SCREW BLUNT TIP
00885556902998 - EVOS2025-05-29 EVOS PELVIC 3.5MM X 22MM LOCKING SCREW BLUNT TIP
00885556903001 - EVOS2025-05-29 EVOS PELVIC 3.5MM X 24MM LOCKING SCREW BLUNT TIP
00885556903018 - EVOS2025-05-29 EVOS PELVIC 3.5MM X 26MM LOCKING SCREW BLUNT TIP
00885556903025 - EVOS2025-05-29 EVOS PELVIC 3.5MM X 28MM LOCKING SCREW BLUNT TIP

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