WELLSTAR

GUDID 00840216125902

GOWN, WELLSTAR ISOLATION AAMI LEVEL 2, YELLOW W/WELLSTAR LOGO IN BLACK INK ON LEFT CHEST, UNIVERSAL, OVER THE HEAD, FULL BACK, TIE WAIST, THUMBHOOK W/ELASTIC WRIST, 10EA/BG, 10BG/CS, (100EA/CS)

Asp Global, LLC

Isolation gown, single-use

• Primary Device ID: 00840216125902
• NIH Device Record Key: 846b6be9-0b72-4eae-90f3-717ee3913e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WELLSTAR
• Version Model Number: WSGNA450L2
• Company DUNS: 080361159
• Company Name: Asp Global, LLC
• Device Count: 1
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840216125902 [Primary]

FDA Product Code

• OEA: Non-Surgical 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: 2024-02-06
• Device Publish Date: 2024-01-29

On-Brand Devices [WELLSTAR]

• 00840216111066: GOWN, WELLSTAR ISOLATION AAMI LEVEL 2, XLARGE, YELLOW W/WELLSTAR LOGO & AAMI2 IN PURPLE INK ON L
• 00840216108677: GOWN, WELLSTAR ISOLATION AAMI LEVEL 2, YELLOW W/WELLSTAR LOGO IN BLACK INK ON LEFT CHEST, UNIVER
• 00840216108325: KIT, WELLSTAR AMENITY
• 00840216125919: GOWN, WELLSTAR ISOLATION AAMI LEVEL 2, XLARGE, YELLOW W/WELLSTAR LOGO & AAMI2 IN PURPLE INK ON L
• 00840216125902: GOWN, WELLSTAR ISOLATION AAMI LEVEL 2, YELLOW W/WELLSTAR LOGO IN BLACK INK ON LEFT CHEST, UNIVER