AccessGUDID - DEVICE: Lightning X Products,Inc (06974567745428)

GUDID

Device Identifier (DI) Information

Brand Name: Lightning X Products,Inc
Version or Model: LXEFB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wuxi Emsrun Technology Co., Ltd.

Primary DI Number: 06974567745428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 542972552 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
10416	Rescue blanket, reusable	A large thin sheet of material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It may be designed as a flat whole-body wrap, blanket or poncho and is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device.	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

Device Exempt from Premarket Submission: Yes 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: 2b83b4ba-46f5-48f3-b8ed-5f1d4d1f3114
Public Version Date: July 25, 2024
Public Version Number: 2
DI Record Publish Date: December 07, 2022