AccessGUDID - DEVICE: CODMAN (10886704043591)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN
Version or Model: AP-03000H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AP03000H
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704043591
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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	001
P890055	002
P890055	003
P890055	006
P890055	010
P890055	011
P890055	013
P890055	014
P890055	015
P890055	017
P890055	019
P890055	052

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
No Device Sizes

Device Record Status

Public Device Record Key: 5c635479-4fc1-41b2-8381-88a27b0e9bfd
Public Version Date: April 03, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2014