DEVICE: Thermoflect (00612899004306)
Device Identifier (DI) Information
Thermoflect
5200-800
In Commercial Distribution
Encompass Group, L.L.C.
5200-800
In Commercial Distribution
Encompass Group, L.L.C.
THERMOFLECT KIT 3, UNIV, 25EA
TS TF KIT, BLKT, CAP, FOOTWEAR, BAG, SILVER, 1/BG, 25 BG/CS
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
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 |
---|---|
KME | Bedding, Disposable, Medical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
932b142b-cdf6-4fcb-b5ae-f8f8dd5f9af9
May 05, 2023
2
November 03, 2022
May 05, 2023
2
November 03, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10612899004303 | 25 | 00612899004306 | 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
[?]
1-800-284-4540
compliance@encompassgroup.net
compliance@encompassgroup.net