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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier ProtectionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612899101104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612899101104006128991011046128991011040612899101104

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-284-4540compliance@encompassgroup.net

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612899045484EncompassVA550-252023-06-22
20612899002726EncompassTP1002023-06-22
20612899004713EncompassG-P91532023-06-22
20612899004720EncompassG-P9163A2023-06-22
20612899005574EncompassG-P91642023-06-22
20612899005581EncompassG-P9165A2023-06-22
20612899005598EncompassG-P91662023-06-22
20612899005604EncompassG-P91512023-06-22
20612899005611EncompassG-P91522023-06-22
20612899005628EncompassG-P91542023-06-22
20612899005635EncompassG-P91552023-06-22
20612899005642EncompassG-P91562023-06-22
20612899005659EncompassG-P9161A2023-06-22
20612899005666EncompassG-P9162A2023-06-22
20612899005673EncompassG-P91642023-06-22
20612899005680EncompassP9165A2023-06-22
20612899005697EncompassP91662023-06-22
20612899005826EncompassG-P91502023-06-22
20612899005864EncompassG-P91602023-06-22
20612899005482EncompassG-P91512023-06-21

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Primary DI, Brand, Company table
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20326053121498Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121504Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
20326053121511Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.QPC2024-11-28
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30197344036312MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
30197344036329MEDLINEMEDLINE INDUSTRIES, INC.QPC2024-08-13
00612899045484EncompassEncompass Group, L.L.C.QPC2023-06-22
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