Poly-Med

GUDID 00850054694911

POLYCONVERSIONS, INC.

Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit Surgical/examination garment kit

• Primary Device ID: 00850054694911
• NIH Device Record Key: 5925966f-7f17-486c-99ed-6fbd9b3a2b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly-Med
• Version Model Number: PLG-4250
• Company DUNS: 825056401
• Company Name: POLYCONVERSIONS, 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054694911 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

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: 2023-09-27
• Device Publish Date: 2023-09-19

Devices Manufactured by POLYCONVERSIONS, INC.

• 00850054694911 - Poly-Med: 2023-09-27
• 00850054694911 - Poly-Med: 2023-09-27
• 00860006079185 - VR: 2021-07-22 VR Thumb Loop Gown, Large 4 Mil Green
• 00860006079192 - VR: 2021-07-22 VR Thumb Loop Gown, Large 4 Mil Green, Case - 50 Ct.
• 00860006079178 - VR: 2021-07-09 VR Thumb Loop Gown, Regular 4 Mil Green
• 10860006079175 - VR: 2021-07-09 VR Thumb Loop Gown, Regular 4 Mil Green, Case - 50 Ct.
• 00860006079109 - VR: 2020-12-29 Sleeve Gloves 15 Mil Extra Large Green Unlined
• 00860006079116 - VR: 2020-12-29 Sleeve Gloves 15 Mil Large Green Unlined
• 00860006079123 - VR: 2020-12-29 Sleeve Gloves 15 Mil Medium Green Unlined