BCI

GUDID 16921200411001

Fuzhou Blue Crystal Industrial Co.,Ltd.

Inflatable hot/cold therapy pack/electric pump

• Primary Device ID: 16921200411001
• NIH Device Record Key: 493806a3-8af4-45bb-9a0a-c0b9b19b701c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCI
• Version Model Number: BCI-CCTS-05
• Company DUNS: 421154057
• Company Name: Fuzhou Blue Crystal Industrial Co.,Ltd.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	16921200411001 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

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: 2018-12-21
• Device Publish Date: 2016-09-16

On-Brand Devices [BCI]

• 16921200413005: BCI-E-CCTS-06
• 16921200412008: BCI-CCTS-05-D
• 16921200411001: BCI-CCTS-05