Hilo

GUDID 00860008076533

Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407. Color: Blue

Hilo Enterprises LLC

Surgical gown, single-use

• Primary Device ID: 00860008076533
• NIH Device Record Key: 7cbabb5a-e27b-4705-a9d4-c8c9c60b26d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hilo
• Version Model Number: S3004
• Company DUNS: 117057129
• Company Name: Hilo Enterprises LLC
• 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	00860008076533 [Primary]

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-12
• Device Publish Date: 2022-01-04

On-Brand Devices [Hilo]

• 00860008076595: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4
• 00860008076588: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE ONLY, LEVEL 4 A
• 00860008076571: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAM
• 00860008076564: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AA
• 00860008076557: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAM
• 00860008076540: Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requir
• 00860008076533: Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets require
• 00860008076526: Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requireme
• 00860008076519: Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST
• 00860008076502: Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM
• 00850038608095: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size XX-LARGE, SINGLE USE ONLY, LEVEL 4
• 00850038608088: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size X-LARGE, SINGLE USE ONLY, LEVEL 4 A
• 00850038608071: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAM
• 00850038608064: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AA
• 00850038608057: Ultra Reinforced Surgical Gown with Poly Reinforcement, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAM
• 00850038608040: Standard Surgical gown, Size XX-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of A
• 00850038608033: Standard Surgical gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AS
• 00850038608026: Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM
• 00850038608019: Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of AST
• 00850038608002: Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM