AccessGUDID - DEVICE: PS-843203 (00850005864356)

GUDID

Device Identifier (DI) Information

Brand Name: PS-843203
Version or Model: PS-843203
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PATHEN MEDICAL LLC

Primary DI Number: 00850005864356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042928915 *Terms of Use

Device Description: 20g x 1” IV CATHETER PURSAFETY S

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?
61650	Peripheral vascular/subcutaneous catheter	A sterile, dual-purpose, thin, flexible tube intended for: 1) insertion into the peripheral vasculature to enable short-term (< 30 days) intravascular access for blood sampling, blood pressure monitoring, fluid/medication administration and/or contrast media injection; and 2) administration of fluids/medication into subcutaneous tissue. It typically includes dedicated accessories to facilitate catheter introduction/function (e.g., connectors, injection ports, stylet, fixation wings, introduction needle). This is a single-use device.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91ebafbc-2aef-4554-bca2-4d767c5b3a01
Public Version Date: October 16, 2023
Public Version Number: 4
DI Record Publish Date: April 24, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20850005864350	4	10850005864353		In Commercial Distribution
10850005864353	50	00850005864356		In Commercial Distribution

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8773185421
Email: questions@pathen.com

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