AccessGUDID - DEVICE: PICC Guard (B38320517205182)

GUDID

Device Identifier (DI) Information

Brand Name: PICC Guard
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PICCGUARD, LLC

Primary DI Number: B38320517205182
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117382745 *Terms of Use

Device Description: Tamper-Evident Catheter Access Cover

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?
64905	Intravenous catheter injection port guard	A box-like device intended to attach to and encompass the proximal end/port of an in situ intravenous catheter to create a protective cover for the prevention of unauthorized intravenous access and/or tampering by the patient or other non-healthcare provider. It typically consists of a plastic box with a locking lid, which cannot be removed without being destroyed and providing tamper evidence. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZW	Catheter Access Cover, Tamper-Resistant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191195	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d59d4af4-c64f-4e95-a191-cd06825a9af0
Public Version Date: November 25, 2024
Public Version Number: 2
DI Record Publish Date: June 09, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 918-519-2563
Email: info@piccguard.com

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