AccessGUDID - DEVICE: Nova (00612899006485)

GUDID

Device Identifier (DI) Information

Brand Name: Nova
Version or Model: AW5100-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Encompass Group, L.L.C.

Primary DI Number: 00612899006485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121788819 *Terms of Use

Device Description: NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 44782433-e7a5-4bfc-bd87-c11ae64f9991
Public Version Date: July 15, 2021
Public Version Number: 1
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-284-4540
Email: COMPLIANCE@ENCOMPASSGROUP.NET

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