AccessGUDID - DEVICE: LoFric® Hydro-Kit™ (07392532138645)

GUDID

Brand Name: LoFric® Hydro-Kit™
Version or Model: 42014
Catalog Number: 4201440
Company Name: Dentsply Ih AB

Primary DI Number: 07392532138645
Issuing Agency: GS1
Device Count: 1

Device Description: Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 14FR

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Single-administration urethral catheterization kit, single-use	A sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Product Code	Product Code Name
EZD	CATHETER, STRAIGHT

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Special Storage Condition, Specify: Store in a dry place at room temperature.

Size Type Text
Catheter Gauge: 14 French
Length: 16 Inch

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: November 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07392532155260	2	07392532155253		In Commercial Distribution	Transport Packaging
07392532155253	20	07392532138645		In Commercial Distribution

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(877)456-3742
Email: info-lofric-usa@wellspect.com