Microdot

GUDID 06971227404916

Promisemed Hangzhou Meditech Co., Ltd.

Manual blood lancing device, single-use

• Primary Device ID: 06971227404916
• NIH Device Record Key: 61aa8914-35ad-4209-9281-cadffc161294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microdot
• Version Model Number: HB-085
• Company DUNS: 421335278
• Company Name: Promisemed Hangzhou Meditech Co., Ltd.
• Device Count: 50
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971227404916 [Primary]
GS1	16971227404913 [Unit of Use]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-04
• Device Publish Date: 2021-09-24

On-Brand Devices [Microdot]

• 16971227404920: HB-100
• 06971227404916: HB-085