FDA.reportPublic FDA data

Deltec

Primary DI
10610586013355
Brand
Deltec
Company
ICU MEDICAL, INC.
Model
21-1501-01
Device description
PAC II TRAY, EPIDURAL, LP, PU, 1.2MM/CS 1/EA
Published
2014-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LNYCatheter, Percutaneous, Long Term, Intraspinal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNYCatheter, Percutaneous, Long Term, IntraspinalUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900052018

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900052018PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEMSmiths Medical Asd, Inc.1991-04-22LNY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610586013355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061058601335510610586013355

GMDN Terms#

Term, Definition table
TermDefinition
Infusion/injection port/catheter, implantableA sterile short- or long-term implantable device composed of a metal or plastic portal with septum, connected to a catheter, intended to be used for the delivery of drugs or other fluids to various anatomical regions or vessels. The device is implanted subcutaneously (under the skin), and delivery of drugs and fluids can be accomplished using a medical (drug/fluid) delivery pump or bolus injection. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10610586013225DeltecICU MEDICAL, INC.LNY2014-09-21