FDA.reportPublic FDA data

Nimbus

Primary DI
40817170020039
Brand
Nimbus
Company
INFUTRONIX LLC
Model
HS-004
Catalog number
HS-004
Device description
Administration set
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30817170020032PackageGS120In Commercial Distribution
40817170020039PackageGS112In Commercial Distribution
00817170020031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081717002003230817170020032
4081717002003940817170020039
00817170020031008171700200318171700200310817170020031

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-650-2007info@infutronix.com

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
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
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

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Primary DI, Brand, Company table
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,Dynarex CorporationFPA2018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, SterileDynarex CorporationFPA2018-05-26