FLTR - Model: PC801;Brand: FLTR;One inner packing box - Shenzhen Pacom Medical Instruments Co., Ltd.

Duns Number:421356348

Device Description: Model: PC801;Brand: FLTR;One inner packing box contains 4 device;One outer packing box con Model: PC801;Brand: FLTR;One inner packing box contains 4 device;One outer packing box contains 5 inner packing boxes.Per outer packing box can pack 20 devices.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

FLTR

Version/Model Number

PC801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190717,K190717,K190717

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

01ad18c9-5f12-43b4-9da5-28a85c78bdd5

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 26, 2020

Additional Identifiers

Package DI Number

10840061480116

Quantity per Package

4

Contains DI Package

00840061480119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner packing box

"SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5