FDA.reportPublic FDA data

Nimbus II Plus

Primary DI
20817170020165
Brand
Nimbus II Plus
Company
INFUTRONIX LLC
Model
Nimbus II Plus
Device description
Ambulatory infusion pump
Published
2019-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MEAPump, Infusion, Pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10817170020168PackageGS11In Commercial Distribution
20817170020165PackageGS160In Commercial Distribution
00817170020161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081717002016810817170020168
2081717002016520817170020165
00817170020161008171700201618171700201610817170020161

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00817170020376Nimbus II EpiDNimbus II EpiD2020-09-02
00817170020154NimbusNimbus Hard Shell 100ml2019-01-15
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
00193494001988ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10193494001985ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
10885403517945AlarisCAREFUSION 303, INC.MEA2023-11-20
10885403516030Alaris™ PCA Module, Model 8120CAREFUSION 303, INC.MEA2023-09-18
00193494000776ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
20193494000770ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
00193494001292ambIT* PIB-PCA v1.5 System w/Male Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001308ambIT* PIB-PCA v1.5 System w/Spike Filter CassAvanos Medical, Inc.MEA2022-11-04
00193494001315ambIT* PIB/PCA Pump V1.5Avanos Medical, Inc.MEA2022-02-24
00193494000707ambIT* PIB-PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494000769ambIT* PIB*IL PumpAvanos Medical, Inc.MEA2022-02-07
00193494000813ambIT* PCA PumpAvanos Medical, Inc.MEA2022-02-07
00193494001216ambIT* KIDS PIB Pump-BlueAvanos Medical, Inc.MEA2022-02-07
00193494001384ambIT* PIB IL v 1.5Avanos Medical, Inc.MEA2022-02-07
00193494000387ambIT* Cassette - Filter, Male Neuraxial ConnectorAvanos Medical, Inc.MEA2022-01-17
10885403494291AlarisCAREFUSION 303, INC.MEA2021-09-29
00817170020376Nimbus II EpiDINFUTRONIX LLCMEA2020-09-02
00850000509078ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-08-17
B101100500PXE0Manufacturing Kit CMExpress® PumpCME AMERICA LLCMEA2020-07-08
00857595005923ambIT SUMMIT MEDICAL PRODUCTS, INC.MEA2020-05-06
00850000509023ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
00850000509030ambITSUMMIT MEDICAL PRODUCTS, INC.MEA2020-04-23
15019517154986CADDICU MEDICAL, INC.MEA2020-02-28
15019517155006CADDICU MEDICAL, INC.MEA2020-02-28
15019517197112PharmGuardICU MEDICAL, INC.MEA2020-01-27
15019517165753CADDICU MEDICAL, INC.MEA2019-12-30
15019517171969CADDICU MEDICAL, INC.MEA2019-12-30
10610586026669CADDICU MEDICAL, INC.MEA2019-12-05
10610586031212CADDICU MEDICAL, INC.MEA2019-12-05
10610586031861CADDICU MEDICAL, INC.MEA2019-12-05