AccessGUDID - DEVICE: Altitude (10884521060982)

GUDID

Device Identifier (DI) Information

Brand Name: Altitude
Version or Model: 8888571371
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8888571371
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521060982
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Chest Drainage Unit,Dry Suction, Dual Drain

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?
36787	Thoracic suction system	An assembly of devices designed to evacuate large volumes of fluid and/or air accumulated between the lung and chest wall (pleural space) by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system is usually employed following thoracic surgery, traumatic chest wounds, barotrauma, or pleural effusions. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c1eef81-4ecd-44e4-8184-76a64046f2ac
Public Version Date: February 15, 2019
Public Version Number: 5
DI Record Publish Date: August 31, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521060989	5	10884521060982		In Commercial Distribution	CASE

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

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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