AccessGUDID - DEVICE: LoFric® Primo™ (07392532135507)

GUDID

Device Identifier (DI) Information

Brand Name: LoFric® Primo™
Version or Model: 41318
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4131840
Company Name: Wellspect AB

Primary DI Number: 07392532135507
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use

Device Description: Single Use Urinary Catheter LoFric Primo Nelaton 8" 18FR

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):	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?
45605	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZD	CATHETER, STRAIGHT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 18 French
Length: 8 Inch

Device Record Status

Public Device Record Key: 231cc813-792b-4aa6-8473-d89ddb5777da
Public Version Date: April 01, 2024
Public Version Number: 5
DI Record Publish Date: November 23, 2016