FDA.reportPublic FDA data

Hygea Sterile Saline Wipe

Primary DI
10310819000304
Brand
Hygea Sterile Saline Wipe
Company
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Model
C22370
Catalog number
C22370
Device description
Wipe used for cleansing with a sterile saline solution where indicated
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10310819000304PackageGS124In Commercial Distribution
00310819000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031081900030410310819000304
00310819000307003108190003073108190003070310819000307

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, sterileA sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch
Width4Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-999-6423pdicustomercare@pdihc.com

Regulatory Flags#

DUNS number
800777117
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310819000031Prevantics® Device Large Swab C71200C712002024-02-15
00310819000482PDI® Lubricating Jelly IIT00137T001372020-10-09
00310819000499PDI® Lubricating Jelly IIT00250T002502020-10-09
00310819000475PDI® Electrode Prep PadB59800B598002020-08-03
00310819000307Hygea Sterile Saline WipeC22370C223702020-08-03
00310819000451PDI® Adhesive Tape Remover PadB16400B164002020-08-03
00310819001526Prevantics® Device Swab B19600B196002020-08-03
10310819000458PDI® Adhesive Tape Remover PadB16400B164002020-08-03
10310819000472PDI® Electrode Prep PadB59800B598002020-08-03
10310819001523Prevantics® Device Swab B19600B196002020-08-03
00310819001779Prevantics® Device Swab StripB123STB123ST2020-08-03

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Primary DI, Brand, Company table
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