Halsted Health

GUDID 00860006105099

Urinary incontinence penis sheath/port, single-use, non-sterile

Primary Device ID	00860006105099
NIH Device Record Key	205546d2-91b7-4b49-987f-617b8f3594e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Halsted Health
Version Model Number	Size 32MM - # 7732-30
Company DUNS	097915269
Company Name	Flex Source International, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00860006105075 [Primary]
GS1	00860006105099 [Package] Contains: 00860006105075 Package: [30 Units] In Commercial Distribution

NNX	Device, Incontinence, Urosheath Type, Non-Sterile

Steralize Prior To Use	false
Device Is Sterile	false

00860006105020	Syringes with needle
00860006105068	Syringes with needle
00860006105099	Silicone Male External Catheter. Self-Adhering. Non-Sterile.
00860006105051	Silicone Male External Catheter. Self-Adhering. Non-Sterile.
00860010400227	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Mark Image Registration \| Serial	Company Trademark Application Date
HALSTED HEALTH 88740641 not registered Live/Pending	Flex Source International, Inc. 2019-12-27