AccessGUDID - DEVICE: CURE CATHETER (00815947020987)

GUDID

Device Identifier (DI) Information

Brand Name: CURE CATHETER
Version or Model: HP8
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00815947020987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: Hydrophilic, Pediatric, 10”, Straight Tip

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?
45603	Single-administration urethral drainage catheter	A sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZD	Catheter, Straight

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132500	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French
Length: 20 Centimeter

Device Record Status

Public Device Record Key: b67c768f-c219-4ba9-8b7c-34ccd0765ba9
Public Version Date: January 09, 2023
Public Version Number: 9
DI Record Publish Date: December 30, 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
20815947020981	10	10815947020984		In Commercial Distribution	Case
10815947020984	30	00815947020987		In Commercial Distribution	Box

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: +18004228811
Email: cic@convatec.com

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