FDA.reportPublic FDA data

Oral Tamper Evident Cap

Primary DI
B21257731001
Brand
Oral Tamper Evident Cap
Company
INTERNATIONAL MEDICAL INDUSTRIES INC.
Model
57-73-100
Catalog number
57-73-100
Device description
Oral Tamper Evident Cap for BD Oral Dispenser. Non-Sterile, Bag of 100, One Bag per Box. Provides Evidence of Access and Positive Closure.
Published
2022-12-22
Public version status
Update
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
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B21257731001PrimaryHIBCC0
B21257731000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-ISO80369-3-standardized oral syringe, single-useA manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [i.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.

Regulatory Flags#

DUNS number
053469565
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B21257701001Oral Tamper Evident Cap57-70-10057-70-1002022-12-22
B2125770IMI1Oral Tamper Evident Cap57-70 IMI57-70 IMI2016-09-23
B21273211Oral Tamper Evident Cap732173212016-10-14
B21231501Chemo Vent31-5031-502016-08-22
B21231201Venting Needle31-2031-202016-08-22
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
B21257731Oral Tamper Evident Cap57-7357-732017-04-28
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
09420060205039haakaaTHINK GREEN LIMITEDKYX2026-09-20
09420060205046haakaaTHINK GREEN LIMITEDKYX2026-09-20