LotFancy

GUDID 86971227402543

The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle

• Primary Device ID: 86971227402543
• NIH Device Record Key: a42e4789-4079-43ea-85b2-b1dbc7587268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LotFancy
• Version Model Number: 11G-2091-K
• Company DUNS: 421335278
• Company Name: Promisemed Hangzhou Meditech Co., Ltd.
• Device Count: 300
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971227402547 [Primary]
GS1	86971227402543 [Unit of Use]

Sterilization

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

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

[86971227402543]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

On-Brand Devices [LotFancy]

• 86971227402543: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 06971227402530: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl