Duns Number:061228290
Device Description: Model 70400 XINFENG Heat Lamp is made from a famous heat lamp manufacturer in China. Floor Model 70400 XINFENG Heat Lamp is made from a famous heat lamp manufacturer in China. Floor Type Style Lamp is contents a replaceable heads with manual controller it's a durable and safety lamp with 5 plastic legs base. Sold by Each.
Catalog Number
70400
Brand Name
XinFeng Heat Lamp
Version/Model Number
70400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
7ad4da8e-a8a9-4891-922b-6dcd8d0a178c
Public Version Date
July 19, 2019
Public Version Number
1
DI Record Publish Date
July 11, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |