FDA.reportPublic FDA data

CARE SCIENCE

Primary DI
20017276236808
Brand
CARE SCIENCE
Company
Aso LLC
Model
017276236804
Device description
Hydrocolloid Gel Blister Cushions, assorted sizes, 1.6 IN x 2.6 IN (42 mm x 68 mm), 0.7 IN x 2.3 IN (20 mm x 60 mm), 0.6 IN x 2.0 IN (17 mm x 51 mm)
Published
2020-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20017276236808PackageGS112In Commercial Distribution
00017276236804PrimaryGS10
60017276236806Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623680820017276236808
00017276236804000172762368040172762368040017276236804
6001727623680660017276236806

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-sterileA non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-823-4545xx@xx.xx

Regulatory Flags#

DUNS number
152793493
Device count
20
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
false
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
00017276241709Rapid Seal0172762417092026-05-27
00017276230734Emoji0172762307342020-04-30
00017276238709CARE SCIENCE0172762387092022-01-24
00017276240818Bluey0172762408182025-08-13
00017276236378Wonder Woman Antibacterial Bandages0172762363782020-04-29
00017276236538LOL Surprise Antibacterial Bandages0172762365382020-02-28
00017276238617Clear Passage Nasal Strips0172762386172021-11-15
00017276221169Garfield017276221169GAR52932020-09-20
00017276230598CarePak0172762305982020-07-29
00017276231854Careband- EMOJI1842562020-09-27
00017276232820Antibacterial PJ Masks Bandages0172762328202020-02-28
00017276233667ALL-HEALTH Adhesive Bandages0172762336670172762336672019-03-29
00017276233841ALL-HEALTH Hydrocolloid Gel Bandages0172762338410172762338412019-03-29
00017276233865ALL-HEALTH Hydrocolloid Gel Bandages0172762338650172762338652019-03-29
00017276233889ALL-HEALTH Hydrocolloid Gel Bandages0172762338890172762338892019-03-29
00017276233896ALL-HEALTH Hydrocolloid Gel Bandages0172762338960172762338962019-03-29
00017276233902ALL-HEALTH Hydrocolloid Gel Cushions0172762339020172762339022019-03-29
00017276233926ALL-HEALTH Hydrocolloid Gel Cushions0172762339260172762339262019-03-29
00017276233933ALL-HEALTH Hydrocolloid Gel Cushions0172762339330172762339332019-03-29
00017276234060ALL-HEALTH Adhesive Bandages0172762340600172762340602019-03-29

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Primary DI, Brand, Company table
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