N/A

GUDID 00857863007895

Mouthpiece, TruFit, Soft Flange, Blue, Vanilla Scent, Disposable

Medi/Nuclear Corporation, Inc.

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use

• Primary Device ID: 00857863007895
• NIH Device Record Key: d6cfbf93-720a-48b3-a6fb-c867e7bf6b49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: MN2550B
• Company DUNS: 079628327
• Company Name: Medi/Nuclear Corporation, Inc.
• 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: 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: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com
• Phone: 800-321-5981
• Email: cs@medinuclear.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857863007857 [Primary]
GS1	00857863007895 [Package]; Contains: 00857863007857; Package: Carton [20 Units]; In Commercial Distribution

FDA Product Code

• BYP: Mouthpiece, Breathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2017-06-09

On-Brand Devices [N/A]

• 00857863007963: Adapter, 15mm ID x 22mm ID
• 00857863007888: Face Mask Harness, Soft Rubber, Adult size
• 00857863007871: Corrugated Tubing, Blue, Scored at 6 inch, 22 mm, 100 FT
• 00857863007895: Mouthpiece, TruFit, Soft Flange, Blue, Vanilla Scent, Disposable
• 00857863007703: Oxygen Tubing Connector, For oxygen tubing, Green
• 00857863007628: Absorbent Paper, 300 ft x 20 in, 2 rolls
• 00857863007697: Ear Plugs, Foam, Pairs Individually Bagged, Polyurethane Foam, PVC Dielectric Cord
• 00857863007666: Oxygen Tubing, 7 feet with Secure-Fit Connector
• 00857863007659: Filter, Bacteria, Disposable