SKYPRO FP3FNWH

GUDID 04897030537042

Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.

SKYPRO ENTERPRISE LIMITED

Surgical/medical face mask, single-use

• Primary Device ID: 04897030537042
• NIH Device Record Key: ce960873-4109-4d5a-874b-48c4be29a4c8
• Commercial Distribution Discontinuation: 2050-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYPRO
• Version Model Number: SP01
• Catalog Number: FP3FNWH
• Company DUNS: 668172323
• Company Name: SKYPRO ENTERPRISE LIMITED
• Device Count: 1
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897030530968 [Package]; Package: Case [40 Units]; Discontinued: 2050-01-01; In Commercial Distribution
GS1	04897030537042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152197

FDA Product Code

• FXX: Mask, Surgical

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: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [SKYPRO]

• 04897030537042: Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patie
• 04897030530982: Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patie