FDA.reportPublic FDA data

Deltec

Primary DI
10610586026171
Brand
Deltec
Company
ICU MEDICAL, INC.
Model
21-2000-24
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLDPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLDPort & Catheter, Implanted, Subcutaneous, IntraperitonealGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864552000PORT-A-CATH IMPLANTABLE CATHETER SYSTEMPharmacia, Inc.1987-03-31LLD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586026171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058602617110610586026171

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port/catheterA fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709204192BivonaZT26IS70NSC117N2026-09-25
10887709204451BivonaSZ26IN60NSB136S2026-09-25
10887709204734BivonaSU26IN45NSZ100N2026-09-25
10887709204901BivonaFT26IN60NGF183N2026-09-25
10887709204918BivonaFT26IN35NGA182N2026-09-25
10887709204925BivonaSF26IN80NSC186N2026-09-25
10887709204932BivonaSF26IN80NSC185N2026-09-25
10887709204949BivonaFT26IN35NGE187N2026-09-25
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847946003364M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946003937M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004118M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004163M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004538M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004583M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004712M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004736M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004750M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004767M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004774M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004781M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946004798M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005023M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005030M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005047M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005054M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005061M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005078M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005085M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005092M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005108M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005115M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005139M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005160M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005177M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005191M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005214M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005238M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19
00847946005368M SERIES BIPHASICZoll Medical CorporationLLD2014-09-19