Paxman Cooling Cap

GUDID B561PSCSCAPASIANSMALL0

PAXMAN COOLERS LIMITED

Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system

Primary Device ID	B561PSCSCAPASIANSMALL0
NIH Device Record Key	aba59b10-b8b6-4ace-a191-effc4a2b2d09
Commercial Distribution Status	In Commercial Distribution
Brand Name	Paxman Cooling Cap
Version Model Number	Small Asian
Company DUNS	519917264
Company Name	PAXMAN COOLERS LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B561PSCSCAPASIANSMALL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163484

FDA Product Code

PMC	Scalp Cooling System

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-09-29
Device Publish Date	2020-09-21

On-Brand Devices [Paxman Cooling Cap]

B561PSCSCAPSMALL0	Small
B561PSCSCAPMEDIUM0	Medium
B561PSCSCAPLARGE0	Large
B561CAPSIZINGPACK1	Sizing pack
B561PSCSCAPASIANSMALL0	Small Asian
B561PSCSCAPASIANMEDIUM0	Medium Asian
B561PSCSCAPASIANLARGE0	Large Asian
B561PSCSCAPMEDSML0	Medium/Small
B561CAPSIZINGPACKA1	Sizing pack Asian
B561CAPBATCH1	Cap Batch