AccessGUDID - DEVICE: NeoMagic (B339350010)

GUDID

Device Identifier (DI) Information

Brand Name: NeoMagic
Version or Model: 350-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350-01
Company Name: NEO MEDICAL INC.

Primary DI Number: B339350010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015510540 *Terms of Use

Device Description: 1.9Fr & 2.0Fr Repair Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
10676	Catheter care kit	A collection of sterile devices designed to clean or otherwise maintain catheter patency. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953300	000

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 Gauge: 2.0 French
Catheter Gauge: 1.9 French

Device Record Status

Public Device Record Key: 64902e48-d807-4a3d-9b82-b66576d8a0c7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B339350015	10	B339350010		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

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

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 888-450-3334
Email: support@neomedicalinc.com

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