DEVICE: Nova (00612899006485)
Device Identifier (DI) Information
Nova
AW5100-200
In Commercial Distribution
Encompass Group, L.L.C.
AW5100-200
In Commercial Distribution
Encompass Group, L.L.C.
NOVA BLANKET, UPPER BODY
NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62340 | Hypothermia-prevention whole-body suit |
A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWJ | System, Thermal Regulating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K203085 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
44782433-e7a5-4bfc-bd87-c11ae64f9991
July 15, 2021
1
July 07, 2021
July 15, 2021
1
July 07, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50612899006480 | 25 | 00612899006485 | In Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-284-4540
COMPLIANCE@ENCOMPASSGROUP.NET
COMPLIANCE@ENCOMPASSGROUP.NET