Beyond BodiHeat®

GUDID 00028373749883

Disposable heat pad for pain relief, non-medicated, apply over-clothing (8ct box)

OKAMOTO USA, INC.

Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use Hot/cold therapy pack, single-use

• Primary Device ID: 00028373749883
• NIH Device Record Key: cc59633c-9f63-4032-8c31-706232bd4649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beyond BodiHeat®
• Version Model Number: 74988
• Company DUNS: 175752724
• Company Name: OKAMOTO USA, INC.
• Device Count: 8
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00028373749883 [Primary]
GS1	80028373749889 [Unit of Use]

FDA Product Code

• IMD: Pack, Hot Or Cold, Disposable

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: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [Beyond BodiHeat®]

• 00028373749883: Disposable heat pad for pain relief, non-medicated, apply over-clothing (8ct box)
• 00028373749845: Disposable heat pad for pain relief, non-medicated, apply over-clothing (4ct box)
• 00028373749838: Disposable heat pad for pain relief, non-medicated, apply over-clothing (3ct pack)
• 00028373749821: Disposable heat pad for pain relief, non-medicated, apply over-clothing (1ct packed in 24ct disp
• 00028373749104: Disposable heat pad for pain relief, non-medicated, apply over-clothing (10ct bag)