FDA.reportPublic FDA data

Tamper Evident Cap for ENFit Syringe

Primary DI
B212H938533101
Brand
Tamper Evident Cap for ENFit Syringe
Company
INTERNATIONAL MEDICAL INDUSTRIES INC.
Model
53310
Catalog number
53310
Device description
Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.
Published
2018-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNREnteral Syringes With Enteral Specific Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNREnteral Syringes With Enteral Specific ConnectorsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170672000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170672000Tamper Evident Cap For use with ENFit SyringesInternational Medical Industries, Inc.2017-10-06PNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B212H938533102PackageHIBCC10In Commercial Distribution
B212H938533101PrimaryHIBCC0
B212H938533100Unit 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
Lot or batch
true

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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10704411006169AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007081AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10704411007104AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit TipAMSINO INTERNATIONAL, INC.PNR2025-06-24
10827989004273Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-04-22
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10192253010923KangarooCardinal Health 200, LLCPNR2025-02-04
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10827989000145Health Care Logistics, Inc®Health Care Logistics, Inc.PNR2025-01-08
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10192253008272KangarooCardinal Health 200, LLCPNR2024-03-08
10192253008289KangarooCardinal Health 200, LLCPNR2024-03-08
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