Additive Port Cap 21-00-100

GUDID B21221001000

"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bag of 100, 1 bag per shipper box"

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap
Primary Device IDB21221001000
NIH Device Record Key75019a3a-c3eb-4e73-a2bd-c236db2137e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdditive Port Cap
Version Model Number21-00-100
Catalog Number21-00-100
Company DUNS053469565
Company NameINTERNATIONAL MEDICAL INDUSTRIES INC.
Device Count100
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
HIBCCB21221001000 [Unit of Use]
HIBCCB21221001001 [Primary]
HIBCCB21221001002 [Package]
Contains: B21221001001
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPEContainer, I.V.

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-07
Device Publish Date2022-09-29

On-Brand Devices [Additive Port Cap]

B21221002"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
B2122100B1000"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
B2122100B2"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
B21221001000"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
B21221021002B. Braun Excel Additive Port Cap
B21221022B. Braun Excel Additive Port Cap
B2122101B100221-01B 100
B2122101B2Tamper Evident Additive Port Cap for IV Bags - Fresenius Kabi, Non-Sterile
B21221012Tamper Evident Additive Port Cap for IV Bags - B. Braun PAB/E3, Non-Sterile
B21221011000100 Unit configuration of Additive Port Cap for B. Braun IV Bags

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