Hygea Sterile Saline Wipe C22370

GUDID 10310819000304

Wipe used for cleansing with a sterile saline solution where indicated

PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile Skin-cleaning wipe, sterile
Primary Device ID10310819000304
NIH Device Record Key0ac5923d-85d4-4377-98c1-a982364f18b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygea Sterile Saline Wipe
Version Model NumberC22370
Catalog NumberC22370
Company DUNS800777117
Company NamePROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com
Phone800-999-6423
Emailpdicustomercare@pdihc.com

Device Dimensions

Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch
Length6 Inch
Width4 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100310819000307 [Primary]
GS110310819000304 [Package]
Contains: 00310819000307
Package: box [24 Units]
In Commercial Distribution

FDA Product Code

FRLFiber, Medical, Absorbent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-11
Device Publish Date2020-08-03

Devices Manufactured by PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

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00310819000499 - PDI® Lubricating Jelly II2020-10-19 Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.
10310819000304 - Hygea Sterile Saline Wipe2020-08-11Wipe used for cleansing with a sterile saline solution where indicated
10310819000304 - Hygea Sterile Saline Wipe2020-08-11 Wipe used for cleansing with a sterile saline solution where indicated
10310819000458 - PDI® Adhesive Tape Remover Pad2020-08-11 To remove adhesive tape from skin.
10310819000472 - PDI® Electrode Prep Pad2020-08-11 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 Strip2020-08-11 Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.

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