FDA.reportPublic FDA data

Nimbus

Primary DI
00814371020044
Brand
Nimbus
Company
ZYNO MEDICAL LLC
Model
Nimbus
Catalog number
Nimbus
Device description
Ambulatory Infusion Pump
Published
2015-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814371020041PackageGS124Not in Commercial Distribution
00814371020044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081437102004110814371020041
00814371020044008143710200448143710200440814371020044

GMDN Terms#

Term, Definition table
TermDefinition
Bedside infusion pump, single-channelAn electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

Contacts#

Phone, Email table
PhoneEmail
866-395-1988support@zynomed.com

Regulatory Flags#

DUNS number
030899271
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814371020013Z-800FZ-800FZ-800F2015-10-13
00814371020020Z-800WZ-800WZ-800W2015-10-13
00814371020037Z-800WFZ-800WFZ-800WF2015-10-13
00814371020006Z-800Z-800Z-8002015-10-13
10814371020058ZynoA2-80070A2-800702016-09-23
10814371020065ZynoA2-80071-DA2-80071-D2016-09-23
10814371020072ZynoA2-80071-DFA2-80071-DF2016-09-23
10814371020089ZynoA2-80071-DF120A2-80071-DF1202016-09-23
10814371020096ZynoA2-80071-PA2-80071-P2016-09-23
10814371020102ZynoA2-80071-PFA2-80071-PF2016-09-23
10814371020119ZynoA2-80072A2-800722016-09-23
10814371020126ZynoA2-80072-FA2-80072-F2016-09-23
10814371020133ZynoA2-80075A2-800752016-09-23
10814371020140ZynoB2-70070B2-700702016-09-23
10814371020157ZynoB2-70071-DB2-70071-D2016-09-23
10814371020164ZynoB2-70071-DFB2-70071-DF2016-09-23
10814371020171ZynoB2-70071-DF120B2-70071-DF1202016-09-23
10814371020188ZynoB2-70071-PB2-70071-P2016-09-23
10814371020195ZynoB2-70072B2-700722016-09-23
10814371020201ZynoB2-70072-FB2-70072-F2016-09-23

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