AccessGUDID - DEVICE: Insuflon (05705244009493)

GUDID

Device Identifier (DI) Information

Brand Name: Insuflon
Version or Model: 98-000-2612
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Unomedical A/S

Primary DI Number: 05705244009493
Issuing Agency: GS1
Commercial Distribution End Date: May 09, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 306032491 *Terms of Use

Device Description: Single use indwelling catheter for multiple subcutaneous injections. The indwelling catheter must be used as described in the Instruction for Use.

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?
17180	Subcutaneous infusion/injection port needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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: Protect from direct sunlight. Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 27 Gauge
Angle: 30 degree

Device Record Status

Public Device Record Key: c2039b5c-af86-4c58-b5b4-a1be1e2af0b8
Public Version Date: May 10, 2024
Public Version Number: 6
DI Record Publish Date: September 15, 2016