AccessGUDID - DEVICE: First PICC™ D/L Peripherally Inserted Central Catheter Basic Kit (00886333209736)

GUDID

Device Identifier (DI) Information

Brand Name: First PICC™ D/L Peripherally Inserted Central Catheter Basic Kit
Version or Model: 384183
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 384183
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333209736
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: First PICC™ D/L Peripherally Inserted Central Catheter Basic Kit 16GA (5F) x 65cm

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":	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?
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Active	true

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 [?]
K972263	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 and Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 16GA (5F) x 65cm

Device Record Status

Public Device Record Key: 85803ee8-e31f-4697-b9cb-ee335437168b
Public Version Date: December 10, 2024
Public Version Number: 5
DI Record Publish Date: September 21, 2016