DEVICE: Nova (00612899006485)

Device Identifier (DI) Information

Nova
AW5100-200
In Commercial Distribution

Encompass Group, L.L.C.
00612899006485
GS1

1
121788819 *Terms of Use
NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DWJ System, Thermal Regulating
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K203085 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

44782433-e7a5-4bfc-bd87-c11ae64f9991
July 15, 2021
1
July 07, 2021
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
800-284-4540
COMPLIANCE@ENCOMPASSGROUP.NET
CLOSE