Home GUDID 00612899101104
Encompass
Primary DI 00612899101104
Brand Encompass
Company Encompass Group, L.L.C.
Model VA550-25XB
Device description NOVAPLUS ISO GOWN, XL, 100EATS NOVAPLUS ISO GOWN, OH APRON, THUMBLOOP, BLUE PE PLASTIC
Published 2023-06-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00612899101104 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00612899101104 00612899101104 612899101104 0612899101104
GMDN Terms# Term, Definition table Term Definition Surgical gown, single-use A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
Regulatory Flags# DUNS number 121788819 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10326053121491 Regard™ Resource Optimization & Innovation, L.L.C. QPC 2024-11-28 10326053121507 Regard™ Resource Optimization & Innovation, L.L.C. QPC 2024-11-28 10326053121514 Regard™ Resource Optimization & Innovation, L.L.C. QPC 2024-11-28 20326053121498 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. QPC 2024-11-28 20326053121504 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. QPC 2024-11-28 20326053121511 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. QPC 2024-11-28 10197344036301 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-09-02 20197344036308 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-09-02 10197344036318 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-08-13 10197344036325 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-08-13 30197344036312 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-08-13 30197344036329 MEDLINE MEDLINE INDUSTRIES, INC. QPC 2024-08-13 00612899045484 Encompass Encompass Group, L.L.C. QPC 2023-06-22 20860005250039 ProtectX The Azac Group QPC 2022-04-07 20860005250060 ProtectX The Azac Group QPC 2022-04-07 20192253003816 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 20192253003823 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 20192253003830 CARDINAL HEALTH CARDINAL HEALTH 200, LLC QPC 2019-05-10 20192253003847 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 20192253003854 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 50192253003817 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 50192253003824 CARDINAL HEALTH CARDINAL HEALTH 200, LLC QPC 2019-05-10 50192253003831 CARDINAL HEALTH CARDINAL HEALTH 200, LLC QPC 2019-05-10 50192253003848 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10 50192253003855 CARDINAL HEALTH Cardinal Health 200, LLC QPC 2019-05-10