Additive Port Cap

Primary DI
B21221002
Brand
Additive Port Cap
Company
INTERNATIONAL MEDICAL INDUSTRIES INC.
Model
21-00
Catalog number
21-00
Device description
"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, 3 bags per shipper box"
Published
2020-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KPEContainer, I.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPEContainer, I.V.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190305000Additive CapInternational Medical Industries, Inc.2019-04-30KPE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B21221002PackageHIBCC3In Commercial Distribution
B21221001PrimaryHIBCC0
B21221000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Syringe tip capA device intended to cover the tip of a syringe (without a needle) in order to prevent the leakage of syringe contents and to maintain content sterility until the syringe is used. This device is typically constructed of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053469565
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2125724STAQ1Tamper Evident Cap57-24 STAQ57-24 STAQ; 57-302 R STAQ2025-03-04
B2125726STAQ1Tamper Evident Cap57-26 STAQ57-26 STAQ; 57-302 W STAQ 2025-03-04
B212172861Oral Tamper Evident Cap17286172862016-10-14
B21257701001Oral Tamper Evident Cap57-70-10057-70-1002022-12-22
B2125770IMI1Oral Tamper Evident Cap57-70 IMI57-70 IMI2016-09-23
B21257731Oral Tamper Evident Cap57-7357-732017-04-28
B21257731001Oral Tamper Evident Cap57-73-10057-73-1002022-12-22
B21257741Oral Tamper Evident Cap57-7457-742016-09-23
B21257751Oral Tamper Evident Cap57-7557-752016-09-23
B2125791R1Tamper Evident Cap with Male Luer Lock57-91 R57-91 R2020-02-13
B212NM57751Tamper Evident Cap for NeoMed Oral DispensersNM-57752018-06-20
B21273211Oral Tamper Evident Cap732173212016-10-14
B2125720501Male Luer Slip Plug57-20-5057-20-502026-01-23
B2125725QUVA1Tamper Evident Cap57-25 QUVA57-25 QUVA2026-01-23
B212576031Female NRFit Tip Cap57-60357-6032026-01-23
B21257700B1Luer Lock Cap57700B57700B2026-01-23
B21257700G1Luer Lock Cap57700G57700G2026-01-23
B21257700R1Luer Lock Cap57700R57700R2026-01-23
B21257700V1Luer Lock Cap57700V57700V2026-01-23
B21257700W1Luer Lock Cap57700W57700W2026-01-23

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Primary DI, Brand, Company table
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18033737862282EVA TPN BagsVALMED SRLKPE2025-12-31
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