FDA.reportPublic FDA data

NEO-prep

Primary DI
20888937016974
Brand
NEO-prep
Company
Coopersurgical, Inc.
Model
44-8000
Device description
NEO-prep Neonatal Skin Prep Tabs - small
Published
2022-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888937016974PackageGS110In Commercial Distribution
30888937016971PackageGS13In Commercial Distribution
00888937016970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893701697420888937016974
3088893701697130888937016971
00888937016970008889370169708889370169700888937016970

GMDN Terms#

Term, Definition table
TermDefinition
Skin moisture barrier dressingA substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1.015Square inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888937027495Endoscopic Seals26153EAU-102026-10-22
00888937027501Endoscopic Seals27550ZAG-102026-10-22
00888937027556Endoscopic SealsC0100132026-10-22
00888937027563Endoscopic SealsC0100142026-10-22
00888937027327ER-SpecC0203002026-08-05
00888937027945ZyMotMulti 850 microLZMH0850M2026-01-23
05060488047336EZ-GripDenudation and Handling Pipettor7-72-28002025-04-11
05060488047343EZ-GripWith Comfort Rest Denudation and Handling Pipettor7-72-28022025-04-11
00888937027334ER-SpecC0203102026-08-05
00888937027341ER-SpecC0203202026-08-05
00888937027358HER-SpecC0206002026-08-05
00888937027365HER-SpecC0206102026-08-05
00888937027372HER-SpecC0206202026-08-05
00888937027389OfficeSPECC0200012026-08-06
00888937027396HER-SpecC0205002026-08-06
00888937027402HER-SpecC0205102026-08-06
00888937027419HER-SpecC0205202026-08-06
00888937027426ER-SPECC020100-12026-08-06
00888937027433ER-SPECC020110-12026-08-06
00888937027440ER-SpecC020120-12026-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998041525Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998041556Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998042782Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054129Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054150Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054181Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054211Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054242Solventum™ Micropore™Solventum US LLCKGX2026-10-23
00197998054273Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054327Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054358Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00197998054396Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-23
00194346726660EquateWAL-MART STORES, INC.KGX2026-10-22
00050428344095CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-16
20665973032423DukalDukal LLCKGX2026-10-14
20665973032430DukalDukal LLCKGX2026-10-14
00050428142677CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428143124CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340523CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428340936CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428341308CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342053CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342121CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428342602CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428346396CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00050428347133CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-10-10
00389152744957Adhesive Sleeve, 10 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00389152745459Adhesive Sleeve, 2 Pack, Tandem MobiTandem Diabetes Care, Inc.KGX2026-10-07
00197998029844Solventum™ Micropore™Solventum Germany GmbHKGX2026-10-05
00311917088556WalgreensWALGREEN CO.KGX2026-09-30