Overhead Cover Gown PM4-88335

GUDID 10842942013949

Overhead Cover Gown, Thumbloop Cuff, Open Back, Universal, Blue.

priMED Medical Products Inc

Professional examination gown, single-use

• Primary Device ID: 10842942013949
• NIH Device Record Key: f45c4b08-6025-4bf6-af02-cee2cf27cc90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overhead Cover Gown
• Version Model Number: Blue
• Catalog Number: PM4-88335
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842942013942 [Primary]
GS1	10842942013949 [Package]; Contains: 00842942013942; Package: Case [6 Units]; In Commercial Distribution
GS1	90842942013945 [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: 2020-09-09
• Device Publish Date: 2020-09-01

Devices Manufactured by priMED Medical Products Inc

• 10842942017503 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, Universal
• 10842942017510 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead AAMI 2 Isolation Gown, Thumbloop With Elastic Cuff, Yellow, XL
• 10842942017527 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, Universal
• 10842942017534 - PRIMED / Caracal: 2025-12-04 PRIMED / Caracal Co-Brand Overhead Film Gown, Thumbloops, Blue, XL
• 10842942017497 - PRIMED: 2025-12-03 ASTM F2100 Level 2 Pediatric Mask | Ear Loops | Dinosaur Pattern
• 10842942017466 - PRIMED / Caracal: 2025-11-28 ASTM Level 1 Mask, Procedure Ear Loops, Blue
• 10842942017473 - PRIMED / Caracal: 2025-11-28 ASTM Level 2 Mask, Procedure Ear Loops, Blue
• 10842942017480 - PRIMED / Caracal: 2025-11-28 ASTM Level 3 Anti-fog Foam Mask, Ultra Soft Ear Loops, Indigo