AccessGUDID - DEVICE: OptiMumm (20884524001101)

GUDID

Device Identifier (DI) Information

Brand Name: OptiMumm
Version or Model: E3635
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 20884524001101
Issuing Agency: GS1
Commercial Distribution End Date: June 24, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Smoke Sponge Guard Tubing

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?
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYD	APPARATUS, EXHAUST, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980915	000

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
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.875 Inch
Length: 10 Feet

Device Record Status

Public Device Record Key: 35d8b461-93d4-42ab-a1e0-153828b50f8a
Public Version Date: June 27, 2025
Public Version Number: 11
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10884524001104	12	20884524001101	2025-06-24	Not 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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