FDA.reportPublic FDA data

CADD

Primary DI
30610586042717
Brand
CADD
Company
ICU MEDICAL, INC.
Model
21-2170-64
Published
2019-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K982839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982839000CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300Sims Deltec, Inc.1998-11-02MEA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586042717PrimaryGS10
10610586034572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061058604271730610586042717
1061058603457210610586034572

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
10
Lot or batch
true
No natural rubber latex
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
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