FDA.reportPublic FDA data

CADD

Primary DI
10610586043628
Brand
CADD
Company
ICU MEDICAL, INC.
Model
21-2130-51
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MEAPump, infusion, pca
MRZACCESSORIES, PUMP, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEAPump, Infusion, PcaGeneral Hospital2
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170982000CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.2017-08-24MEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586043628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058604362810610586043628

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator) or when it is designed to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13
10887709198057BivonaFT26GN35NGE060N2026-07-13
10887709198071BivonaFT26GN60NSC063N2026-07-13
10887709198088BivonaFT26GN45NGF056N2026-07-13
10887709198125BivonaFT26GN35NSE071N2026-07-13
10887709198132BivonaFT26GN35NSE072N2026-07-13
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00193494001988ambIT* DISPOSABLE PLUSAvanos Medical, Inc.MEA2025-08-27
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
17290109152254AvosetPadEITAN MEDICAL LTDMRZ2023-08-09
17290109152278Avoset AAP Cradle EITAN MEDICAL LTDMRZ2023-08-09
00193494000776ambIT* Remote Bolus SwitchAvanos Medical, Inc.MEA2023-04-05
17290109154302Sapphire ConnectEITAN MEDICAL LTDMRZ2023-03-26
17290109154494Sapphire Connect Power SupplyEITAN MEDICAL LTDMRZ2023-03-26
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
17290109154074Multi-Pump Mounting System compatible with IPS- AEITAN MEDICAL LTDMRZ2022-05-16
17290109153886Sapphire power supply-US (interchangeble heads)EITAN MEDICAL LTDMRZ2022-05-15
17290109153893Splitter - US EITAN MEDICAL LTDMRZ2022-05-15
17290109153930Sapphire Multi-Pump Mounting System Power Supply – USEITAN MEDICAL LTDMRZ2022-05-15
17290109153947PCA Lockbox 250mLEITAN MEDICAL LTDMRZ2022-05-15
17290109153954PCA Lockbox 100 ml EITAN MEDICAL LTDMRZ2022-05-15
17290109153961Integrated power supply EITAN MEDICAL LTDMRZ2022-05-15
17290109153978Bolus handle - USEITAN MEDICAL LTDMRZ2022-05-15
17290109153992Sapphire External Battery PackEITAN MEDICAL LTDMRZ2022-05-15
17290109154029Mini Cradle with Splitter - USEITAN MEDICAL LTDMRZ2022-05-15