Nimbus II EpiD

GUDID 00817170020376

Ambulatory infusion pump

INFUTRONIX LLC

Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump
Primary Device ID00817170020376
NIH Device Record Keyf71db85a-a8d7-4701-a189-d36f562af8e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNimbus II EpiD
Version Model NumberNimbus II EpiD
Company DUNS079821136
Company NameINFUTRONIX LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817170020376 [Primary]
GS110817170020373 [Package]
Package: Inner Pack [1 Units]
In Commercial Distribution
GS120817170020370 [Package]
Contains: 10817170020373
Package: Case [60 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-10
Device Publish Date2020-09-02

Devices Manufactured by INFUTRONIX LLC

00817170020376 - Nimbus II EpiD2020-09-10Ambulatory infusion pump
00817170020376 - Nimbus II EpiD2020-09-10 Ambulatory infusion pump
20817170020165 - Nimbus II Plus2019-03-14 Ambulatory infusion pump
00817170020154 - Nimbus2019-02-15 This is a plastic box outside a drug bag less than or equal to 100ml.
10817170020083 - Nimbus II PainPRO2018-10-29 Ambulatory infusion pump
40817170020046 - Nimbus2018-07-06 Administration set
10817170020090 - Nimbus II Flex2018-07-06 Ambulatory infusion pump
10817170020106 - Nimbus2018-07-06 Ambulaotry infusion pump
10817170020007 - Nimbus2018-03-29 Ambulatory infusion pump

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