AccessGUDID - DEVICE: INTERA (00850014110147)

GUDID

Device Identifier (DI) Information

Brand Name: INTERA
Version or Model: AP-03000H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AP03000H
Company Name: Intera Oncology Inc.

Primary DI Number: 00850014110147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117070072 *Terms of Use

Device Description: Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34071	Implantable intrathecal infusion pump, nonprogrammable	A battery-powered nonprogrammable device designed to be implanted in a patient for the storing and subarachnoid administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a refillable drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LKK	Pump, Infusion, Implanted, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890055	074

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Protect Package from Water
Special Storage Condition, Specify: Do not drop
Special Storage Condition, Specify: Do not use if opened or damaged

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: 571c7621-35c9-42d4-ac45-92a7abd9fc51
Public Version Date: April 15, 2024
Public Version Number: 4
DI Record Publish Date: July 28, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-909-4815
Email: interaoncology-us@healthlinkeurope.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES