Model: 3
Catalog: 2051720518
DI: B38320517205183
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Tamper-evident catheter access cover
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9e6d0f3b-950e-4411-a79e-9829546023e5
Distribution Status:
In Commercial Distribution
DUNS Number:
117382745
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B38320517205183
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 64905
Name: Intravenous catheter injection port guard
Definition:
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.
FDA Product Codes
PZW
Catheter Access Cover, Tamper-Resistant
Premarket Submissions
Submission Number:
K191195
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Storage Handling - Storage Handling High - @attributes - Value:
100
Storage Handling - Storage Handling Type:
Handling Environment Temperature