Protective Pediatric Mitts MTPM391M

GUDID 00027479280122

Protective Pediatric Mitts - Size Toddler (1-3 Years) - Pair

MEDI-TECH INTERNATIONAL CORPORATION

Limb/torso/head restraint, reusable

• Primary Device ID: 00027479280122
• NIH Device Record Key: d4de62a7-76ff-40ef-a3d3-ada2cc344f1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protective Pediatric Mitts
• Version Model Number: MTPM391M
• Catalog Number: MTPM391M
• Company DUNS: 063865158
• Company Name: MEDI-TECH INTERNATIONAL CORPORATION
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 414-570-8880
• Email: Marilyn.Geiger@medi-techintl.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00027479280122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110377

FDA Product Code

• FMQ: Restraint, Protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-07-23

On-Brand Devices [Protective Pediatric Mitts]

• 00027479280139: Protective Pediatric Mitts - Size Youth (3-7 Years) - Pair
• 00027479280122: Protective Pediatric Mitts - Size Toddler (1-3 Years) - Pair
• 00027479280115: Protective Pediatric Mitts - Size Infant (0-1 Years) - Pair