AccessGUDID - DEVICE: UNO Plus 300 CC Collection Canister (00849405000488)

GUDID

Device Identifier (DI) Information

Brand Name: UNO Plus 300 CC Collection Canister
Version or Model: UP-S00D3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENADYNE BIOTECHNOLOGIES INC.

Primary DI Number: 00849405000488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006616130 *Terms of Use

Device Description: All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: 200cc (Ref#: UP-S00D2) 300cc (Ref#: UP-S00D3) Each canister is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375” side and chevron seals). The canister is sterilized using EO sterilization method and has a shelf life of 3 years.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
47404	Negative-pressure wound therapy system canister	A receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	Negative Pressure Wound Therapy Powered Suction Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210107	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 139548c0-eb63-4251-a8d9-ae84424d9f1e
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023