Tamper Evident Cap for ENFit Syringe 53310

GUDID B212H938533101

Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.

INTERNATIONAL MEDICAL INDUSTRIES INC.

Syringe tip cap

• Primary Device ID: B212H938533101
• NIH Device Record Key: 7ecb1ed8-64e1-4c8f-88cf-8d464cda12c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap for ENFit Syringe
• Version Model Number: 53310
• Catalog Number: 53310
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 100
• 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: false
• 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	B212H938533100 [Unit of Use]
HIBCC	B212H938533101 [Primary]
HIBCC	B212H938533102 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170672

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-06
• Device Publish Date: 2018-01-29

Devices Manufactured by INTERNATIONAL MEDICAL INDUSTRIES INC.

• B2125726SCA2 - Tamper Evident Cap for Luer Lock IV Syringes: 2024-03-29 Tamper Evident Cap for Luer Lock IV Syringes with SCA logo
• B21257302SCA2 - Tamper Evident Cap for Luer Lock IV Syringes Bulk Pouch: 2024-03-29 Tamper Evident Cap for Luer Lock IV Syringes Bulk Pouch with SCA logo
• B21221011000 - Additive Port Cap: 2023-09-18 100 Unit configuration of Additive Port Cap for B. Braun IV Bags
• B21257220100RFID0 - Tamper Evident Cap for use with ENFit: 2023-09-18 Tamper Evident Cap for Use With ENFit® Syringes (ETEC)
• B21257302B0 - Tamper Evident Cap for Luer Lock IV Syringes: 2023-08-08 Tamper Evident Cap for Luer Lock IV Syringes
• B21257302R2 - Tamper Evident Cap for Luer Lock IV Syringes: 2023-08-08 Tamper Evident Cap for Luer Lock IV Syringe
• B21257302W2 - Tamper Evident Cap for Luer Lock IV Syringes: 2023-08-08 Tamper Evident Cap for Luer Lock IV Syringes
• B21257352B0 - Tamper Evident Cap for Luer Lock IV Syringes: 2023-08-08 Tamper Evident Cap for Luer Lock IV Syringes