PICC Guard

Primary DI
B38320517205183
Brand
PICC Guard
Company
PICCGUARD, LLC
Model
3
Catalog number
2051720518
Device description
Tamper-evident catheter access cover
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZWCatheter Access Cover, Tamper-Resistant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZWCatheter Access Cover, Tamper-ResistantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191195000PiccGuardPiccguard, LLC2020-01-03PZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B38320517205183PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous catheter injection port guardA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit100 Degrees Fahrenheit

Regulatory Flags#

DUNS number
117382745
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B38320517205182PICC Guard22023-06-09
B38320517205181PICC Guard120517205182020-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B38320517205182PICC GuardPICCGUARD, LLCPZW2023-06-09
B38320517205181PICC GuardPICCGUARD, LLCPZW2020-06-28