SURGIPLUS 68-6149-B

GUDID 84895237141532

Warm-up Jacket, Blue, XL A non-sterile garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically a shirt composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

KENPAX INTERNATIONAL LIMITED

Scrub suit, single-use, non-sterile

• Primary Device ID: 84895237141532
• NIH Device Record Key: 047730d2-b8bd-40b2-b896-57dbc6e26496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGIPLUS
• Version Model Number: 1
• Catalog Number: 68-6149-B
• Company DUNS: 686206765
• Company Name: KENPAX INTERNATIONAL LIMITED
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	74895237141535 [Primary]
GS1	84895237141532 [Package]; Contains: 74895237141535; Package: case [25 Units]; In Commercial Distribution

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [SURGIPLUS]

• 84895237109013: Procedure Mask Face mask wiht earloop, Blue 178X95 cm
• 84895237108061: Scrub Pant, 2XL A non-sterile, two-piece garment designed to be worn by healthcare staff to faci
• 84895237108054: Scrub Pant, XL A non-sterile, two-piece garment designed to be worn by healthcare staff to facil
• 84895237108047: Scrub Pant, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facili
• 84895237108030: Scrub Shirt, 2XL A non-sterile, two-piece garment designed to be worn by healthcare staff to fac
• 84895237108023: Scrub Shirt, XL A non-sterile, two-piece garment designed to be worn by healthcare staff to faci
• 84895237108016: Scrub Shirt, L A non-sterile, two-piece garment designed to be worn by healthcare staff to facil
• 84895237108092: Scrub Pant, M A non-sterile, two-piece garment designed to be worn by healthcare staff to facili
• 84895237108078: Scrub Shirt, M A non-sterile, two-piece garment designed to be worn by healthcare staff to facil
• 84895237141532: Warm-up Jacket, Blue, XL A non-sterile garment designed to be worn by healthcare staff to facili
• 84895237141525: Warm-up Jacket, Blue, L A non-sterile garment designed to be worn by healthcare staff to facilit
• 74895237141511: Warm-up Jacket, Blue A non-sterile garment designed to be worn by healthcare staff to facilitate