FDA.reportPublic FDA data

INTERA

Primary DI
10850014110045
Brand
INTERA
Company
INTERA ONCOLOGY INC.
Model
AP-04013-5
Catalog number
AP040135
Device description
Special Bolus Needle for use with Intera 3000 Hepatic Artery Infusion Pump Straight Length 1 3/8" (3.5cm)
Published
2021-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKKPump, Infusion, Implanted, Programmable
PTINon-Coring (Huber) Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKKPump, Infusion, Implanted, ProgrammableUnknown3
PTINon-Coring (Huber) NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211121000
P890055073

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211121000Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.2021-10-14PTI
P890055073MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014110045PackageGS15In Commercial Distribution
00850014110048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001411004510850014110045
00850014110048008500141100488500141100480850014110048

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.375Inch
Needle Gauge20Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-660-2660interaoncology-us@healthlinkeurope.com
800-660-2660orders@interaoncology.com

Regulatory Flags#

DUNS number
117070072
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014110024INTERAAP-04011AP040112021-06-23
00850014110048INTERAAP-04013-5AP0401352021-10-06
00850014110055INTERAAP-04032-5AP0403252021-06-23
00850014110147INTERAAP-03000HAP03000H2021-07-28
00850014110154INTERAAP-07004AP070042021-07-28
00850014110093INTERAIP-37957IP379572021-07-13
00850014110017INTERAAP-04009AP040092021-10-18
00850014110031INTERAAP-04030AP040302021-10-18
00850014110130INTERAAP-07004AP070042021-10-18
00850014110079INTERAAP-07014USAP07014US2021-08-13
10850014110014INTERAAP-04009AP040092021-10-18
10850014110038INTERAAP-04030AP040302021-10-18
10850014110021INTERAAP-04011AP040112021-06-23
10850014110052INTERAAP-04032-5AP0403252021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987488111298K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111304K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111311K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111328K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111335K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111342K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111359K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111366K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111373K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111380K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111397K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
04987488111403K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSB-KAWASUMI LABORATORIES, INC.PTI2026-05-31
00199150021277NAMEDTRONIC, INC.LKK2026-05-02
00801741239403SafeStepBard Access Systems, Inc.PTI2026-04-07
00763000999414SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000999421SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000004101NAMEDTRONIC, INC.LKK2025-08-25
00801741235238PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235245PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235252PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
00801741235269Safe StepBard Access Systems, Inc.PTI2025-04-10
00801741235283Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741235235PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235242PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
20801741235256PowerLoc MaxBard Access Systems, Inc.PTI2025-04-10
10801741235266Safe StepBard Access Systems, Inc.PTI2025-04-10
10801741235280Safe StepBard Access Systems, Inc.PTI2025-04-10
00763000574598NAMEDTRONIC, INC.LKK2025-02-10
00801741232350AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05
00801741232367AllPoints Port Access System PowerLoc MaxBard Access Systems, Inc.PTI2024-12-05