AccessGUDID - DEVICE: SKYPRO (04897030537042)

GUDID

Device Identifier (DI) Information

Brand Name: SKYPRO
Version or Model: SP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP3FNWH
Company Name: SKYPRO ENTERPRISE LIMITED

Primary DI Number: 04897030537042
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 668172323 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35177	Surgical/medical face mask, single-use	A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FXX	Mask, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152197	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce960873-4109-4d5a-874b-48c4be29a4c8
Public Version Date: January 17, 2022
Public Version Number: 5
DI Record Publish Date: December 08, 2020