AccessGUDID - DEVICE: LoFric® Origo™ (07392532122576)

GUDID

Device Identifier (DI) Information

Brand Name: LoFric® Origo™
Version or Model: 44414
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4441440
Company Name: Wellspect AB

Primary DI Number: 07392532122576
Issuing Agency: GS1
Commercial Distribution End Date: October 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 351118942 *Terms of Use

Device Description: Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH14 / Coudé 16" 14FR, Sterile device.

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?
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
Length: 16 Inch
Catheter Gauge: 14 French

Device Record Status

Public Device Record Key: fb60a3f3-610c-4f14-8e02-3b76ec1eaddf
Public Version Date: October 16, 2023
Public Version Number: 8
DI Record Publish Date: November 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status
07392532154331	4	07392532154324	2023-10-13	Not in Commercial Distribution
07392532154324	30	07392532122576	2023-10-13	Not in Commercial Distribution
07392532183164	5	07392532122576	2023-10-13	Not in Commercial Distribution