Tamper Evident Additive Port Cap 21-03-100

GUDID B21221031002

"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bags of 50, 2 bags per shipper box"

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap
Primary Device IDB21221031002
NIH Device Record Keyb3597b8f-8ffa-48f0-9a87-9ea2084a70df
Commercial Distribution StatusIn Commercial Distribution
Brand NameTamper Evident Additive Port Cap
Version Model Number21-03-100
Catalog Number21-03-100
Company DUNS053469565
Company NameINTERNATIONAL MEDICAL INDUSTRIES INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB21221031000 [Unit of Use]
HIBCCB21221031001 [Primary]
HIBCCB21221031002 [Package]
Contains: B21221031001
Package: Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPEContainer, I.V.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-18
Device Publish Date2022-10-10

On-Brand Devices [Tamper Evident Additive Port Cap]

B21221031002"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that
B21221032"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that

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