Tamper Evident Cap with Male Luer Lock 57-91 R

GUDID B2125791R2

Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box

INTERNATIONAL MEDICAL INDUSTRIES INC.

Intravenous administration set

• Primary Device ID: B2125791R2
• NIH Device Record Key: 32ea9297-7f9e-4e3d-b5d0-9b9a0dd44287
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap with Male Luer Lock
• Version Model Number: 57-91 R
• Catalog Number: 57-91 R
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2125791R1 [Primary]
HIBCC	B2125791R2 [Package]; Contains: B2125791R1; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182545

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-21
• Device Publish Date: 2020-02-13

Devices Manufactured by INTERNATIONAL MEDICAL INDUSTRIES INC.

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• B21257700G2 - Luer Lock Cap: 2026-02-02 Luer Lock Cap
• B21257700R2 - Luer Lock Cap: 2026-02-02 Luer Lock Cap
• B21257700V2 - Luer Lock Cap: 2026-02-02 Luer Lock Cap
• B21257700W2 - Luer Lock Cap: 2026-02-02 Luer Lock Cap