PRIMED / Caracal

GUDID 10842942017534

PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, XL

priMED Medical Products Inc

Professional examination gown, single-use

• Primary Device ID: 10842942017534
• NIH Device Record Key: 0c59dcb4-b22a-4e83-b5d6-f6ee48495fbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMED / Caracal
• Version Model Number: CPS88335XL
• Company DUNS: 253287569
• Company Name: priMED Medical Products Inc
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, and well ventilated space out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842942017537 [Primary]
GS1	10842942017534 [Package]; Contains: 00842942017537; Package: Case [6 Units]; In Commercial Distribution
GS1	90842942017530 [Unit of Use]

FDA Product Code

• FME: Gown, Examination

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-04
• Device Publish Date: 2025-11-26

On-Brand Devices [PRIMED / Caracal]

• 10842942017480: ASTM Level 3 Anti-fog Foam Mask, Ultra Soft Ear Loops, Indigo
• 10842942017473: ASTM Level 2 Mask, Procedure Ear Loops, Blue
• 10842942017466: ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942017534: PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, XL
• 10842942017527: PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, Universal
• 10842942017510: PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, X
• 10842942017503: PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, U