Guarded Luer Connector Female to Male

Primary DI
B212574012
Brand
Guarded Luer Connector Female to Male
Company
INTERNATIONAL MEDICAL INDUSTRIES INC.
Model
57-401
Catalog number
57-401
Device description
Guarded Luer Connector Female to Male, Yellow, Sterile, Box of 50 individual blisters.
Published
2018-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173577000Guarded Luer ConnectorInternational Medical Industries, Inc.2018-06-07LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B212574012PackageHIBCC50In Commercial Distribution
B212574011PrimaryHIBCC0
B212574010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053469565
Device count
50
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
true
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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