AccessGUDID - DEVICE: CODMAN® (10381780520719)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN®
Version or Model: 826880
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-6880
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780520719
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use

Device Description: CODMAN® Patient Monitor Interface Cable Draeger/Siemens (10 pin)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
61435	Intracranial/compartmental-pressure monitor calibrator/cable	An electronic device intended to generate a reference baseline for the standardization of readings of intracranial pressure (ICP) and/or pressure in a muscle compartment, and to transfer the readings from a catheter (i.e., intracerebral sensor or compartmental-pressure catheter) to a pressure monitor. It consists of a small unit with input and output cables to make electrical connections between a catheter connection cable and the patient monitor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, monitoring, intracranial pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152670	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Waste Electrical and Electronic Equipment
Handling Environment Temperature: between 32 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f34a6b4b-7c67-4366-9ca6-c38df4c94e50
Public Version Date: May 16, 2023
Public Version Number: 6
DI Record Publish Date: April 01, 2020

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)654-2873
Email: custsvcnj@integralife.com

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