Hygea Sterile Saline Wipe C22370

GUDID 10310819000304

Skin-cleaning wipe, sterile

Primary Device ID	10310819000304
NIH Device Record Key	0ac5923d-85d4-4377-98c1-a982364f18b7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Hygea Sterile Saline Wipe
Version Model Number	C22370
Catalog Number	C22370
Company DUNS	800777117
Company Name	PROFESSIONAL DISPOSABLES 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	false
Serial Number	false
Manufacturing Date	false
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 Issuing Agency	Device ID
GS1	00310819000307 [Primary]
GS1	10310819000304 [Package] Contains: 00310819000307 Package: box [24 Units] In Commercial Distribution

FRL	Fiber, Medical, Absorbent

Steralize Prior To Use	false
Device Is Sterile	true

00310819000031 - Prevantics® Device Large Swab	2024-02-23 Pre-moistened swab to disinfect needleless access sites prior to use.
00310819000482 - PDI® Lubricating Jelly II	2020-10-19 Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.
00310819000499 - PDI® Lubricating Jelly II	2020-10-19 Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.
10310819000304 - Hygea Sterile Saline Wipe	2020-08-11Wipe used for cleansing with a sterile saline solution where indicated
10310819000304 - Hygea Sterile Saline Wipe	2020-08-11 Wipe used for cleansing with a sterile saline solution where indicated
10310819000458 - PDI® Adhesive Tape Remover Pad	2020-08-11 To remove adhesive tape from skin.
10310819000472 - PDI® Electrode Prep Pad	2020-08-11 Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.
10310819001523 - Prevantics® Device Swab	2020-08-11 Pre-moistened swab to disinfect needleless access sites prior to use.
00310819001779 - Prevantics® Device Swab Strip	2020-08-11 Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.