FDA.reportPublic FDA data

CADD

Primary DI
15019517101034
Brand
CADD
Company
ICU MEDICAL, INC.
Model
2110
Catalog number
21-2112-0401-78
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
15019517101034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951710103415019517101034

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container 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 the device is designed to power a cordless devices (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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02
10887709194738BivonaFP26FN35NSA007N2026-06-02
10887709194745BivonaFT26FN35NGE008N2026-06-02
10887709194752BivonaHT26FS85NSC009N2026-06-02
10887709194769BivonaFT26FN40NGF012N2026-06-02
10887709194776BivonaFT26FN35NSE011N2026-06-02
10887709194783BivonaXT26FS50NSA010N2026-06-02
10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
17290109154036Mini Cradle EITAN MEDICAL LTDMRZ2022-05-15
17290109154081Multi-Pump Mounting System Compatible with IPS- B KitEITAN MEDICAL LTDMRZ2022-05-15