FDA.reportPublic FDA data

Nimbus II EpiD

Primary DI
00817170020376
Brand
Nimbus II EpiD
Company
INFUTRONIX LLC
Model
Nimbus II EpiD
Device description
Ambulatory infusion pump
Published
2020-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion
MEAPump, Infusion, Pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MEAPump, Infusion, PcaGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153193000Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC2016-08-30FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817170020373PackageGS11In Commercial Distribution
20817170020370PackageGS160In Commercial Distribution
00817170020376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081717002037310817170020373
2081717002037020817170020370
00817170020376008171700203768171700203760817170020376

GMDN Terms#

Term, Definition table
TermDefinition
Patient-controlled analgesia infusion pumpA battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079821136
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817170020000NimbusNimbus2016-09-23
00817170020086Nimbus II PainPRONimbus II PainPRO2017-05-22
00817170020093Nimbus II FlexNimbus II Flex2017-07-05
00817170020109NimbusNimbus II EMS2017-08-31
00817170020161Nimbus II PlusNimbus II Plus2019-03-06
00817170020154NimbusNimbus Hard Shell 100ml2019-01-15
20817170020165Nimbus II PlusNimbus II Plus2019-03-06
10817170020083Nimbus II PainPRONimbus II PainPRO2017-05-22
00817170020048NimbusHS-002HS-0022017-07-31
40817170020046NimbusHS-002HS-0022017-07-31
10817170020090Nimbus II FlexNimbus II Flex2017-07-05
10817170020106NimbusNimbus II EMS2017-08-31
00817170020017NimbusHS-001HS-0012016-09-23
00817170020024NimbusHS-003HS-0032016-09-23
00817170020031NimbusHS-004HS-0042016-11-15
10817170020007NimbusNimbus2016-09-23
20817170020011NimbusHS-001HS-0012016-09-23
20817170020028NimbusHS-003HS-0032016-09-23
40817170020039NimbusHS-004HS-0042016-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856038001942IradimedIRADIMED CORP.FRN2026-10-08
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10885403519451BD Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.MEA2026-10-08
10885403519468Alaris™ PCA Module, Model 8120CAREFUSION 303, INC.MEA2026-10-08
10885403533211BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533259Alaris™ PCA Module Model 8120CAREFUSION 303, INC.MEA2026-10-08
10885403533266Alaris™ PCA Module Model 8120CAREFUSION 303, INC.MEA2026-10-08
10885403533273BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533297BD Alaris™ PCU Model 8015CAREFUSION 303, INC.FRN2026-10-08
10885403533334BD Alaris™ Syringe Module Model 8110CAREFUSION 303, INC.FRN2026-10-08
10885403533426BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403535215BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
10885403542930BD Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2026-10-08
05060844770014SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770021SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770038SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770045SAFIRAMEDOVATE LIMITEDFRN2026-10-05
05060844770052SAFIRAMEDOVATE LIMITEDFRN2026-10-05
04046955664214B.BRAUNB. BRAUN MEDICAL INC.FRN2026-07-12
04046961034704Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
04046961034834Perfusor®B. BRAUN MEDICAL INC.FRN2026-06-25
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29