HYH

GUDID 30680651881787

BASIC PACK XV

O&M HALYARD, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 30680651881787
• NIH Device Record Key: f76e64cf-d6a0-432c-adbe-af1b95756fb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYH
• Version Model Number: 88178
• Company DUNS: 081057389
• Company Name: O&M HALYARD, 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: false
• 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

Customer Support Contacts

• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx
• Phone: +1(844)425-9273
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10680651881783 [Primary]
GS1	30680651881787 [Package]; Contains: 10680651881783; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083234

FDA Product Code

• KKX: Drape, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-11-06
• Device Publish Date: 2015-12-15

On-Brand Devices [HYH]

• 30680651888311: OB PACK III
• 30680651887628: UNIVERSAL PACK, SMALL
• 30680651881787: BASIC PACK XV