FDA.reportPublic FDA data

ABD Device

Primary DI
05391540450079
Brand
ABD Device
Company
AQUILA BIOSCIENCE LIMITED
Model
ABD-S0002
Device description
ABD DeviceEmergency response against harmful bacteria & virusesNon-Toxic Decontamination for use on Skin
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MACDecontamination Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MACDecontamination KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391540450079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391540450079053915404500795391540450079

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cleaning wipe, non-sterileA non-sterile device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+353091734007info@aquilabioscience.com

Regulatory Flags#

DUNS number
985522430
Device count
1
Premarket exempt
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618029791399SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029830241SageSAGE PRODUCTS, LLCMAC2023-10-22
00618029850188SageSAGE PRODUCTS, LLCMAC2023-10-22
50618029850183SageSAGE PRODUCTS, LLCMAC2023-10-22
20653160139161CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
00653160233421CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160233428CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160139164CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-02
10653160240754CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160287919CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160294207CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160313120CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019285CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160019964CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160021868CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160024975CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160027075CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160053203CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160065848CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160119411CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160201024CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
00653160209891CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019280CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160019969CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160021863CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160024970CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160027070CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160053208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
50653160065843CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01
10653160119418CenturionCENTURION MEDICAL PRODUCTS CORPORATIONMAC2022-01-01