AccessGUDID - DEVICE: PowerStick (B3393012116180)

GUDID

Device Identifier (DI) Information

Brand Name: PowerStick
Version or Model: 30121-1618
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30121-1618
Company Name: NEO MEDICAL INC.

Primary DI Number: B3393012116180
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015510540 *Terms of Use

Device Description: PowerStick 20ga x 18cm, Power Rated EPIV with MST

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	A collection of 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
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071875	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 Away From Sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Pressure: 300 Pound per Square Inch
Catheter Gauge: 3.0 French
Length: 18.0 Centimeter

Device Record Status

Public Device Record Key: 52fb86ba-81b4-4384-83b9-ab17d9a9685e
Public Version Date: August 02, 2023
Public Version Number: 4
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
B3393012116185	10	B3393012116180		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: Yes CLOSE

Customer Contact

[?]

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

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