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
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

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