AccessGUDID - DEVICE: NeoMagic (B339194716060)

GUDID

Device Identifier (DI) Information

Brand Name: NeoMagic
Version or Model: 1947-1606
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1947-1606
Company Name: NEO MEDICAL INC.

Primary DI Number: B339194716060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015510540 *Terms of Use

Device Description: 1.9Fr x 6cm Single Lumen Polyurethane EPIV with Stylet & 27ga Sharps Safety Tearaway Sheath Introducer

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
64573	Peripheral intravenous catheterization kit, non-sensing	A collection of non-powered devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. 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: Keep Dry
Special Storage Condition, Specify: Keep Away From Sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 6 Centimeter
Catheter Gauge: 1.9 French
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: bf9b688d-b659-4ad4-aadb-cc8b00c800cc
Public Version Date: April 18, 2025
Public Version Number: 4
DI Record Publish Date: March 11, 2022