AccessGUDID - DEVICE: Duette™ (20852732004047)

GUDID

Device Identifier (DI) Information

Brand Name: Duette™
Version or Model: K-10016
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: POIESIS MEDICAL, LLC

Primary DI Number: 20852732004047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 831415109 *Terms of Use

Device Description: 16FR Duette™ Indwelling Urinary Catheter Tray

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
32031	Indwelling urethral catheterization kit, adult	A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHR	Catheter care tray

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Out of Sunlight
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 16 French

Device Record Status

Public Device Record Key: 4494b269-70bb-4dec-9cd9-7bb1d2f2e998
Public Version Date: December 04, 2020
Public Version Number: 3
DI Record Publish Date: January 27, 2017

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: 00852732004043 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)487-5740
Email: sales@poiesismedical.com

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