FDA.reportPublic FDA data

Air Assist

Primary DI
00860012876808
Brand
Air Assist
Company
GASTRO CONCEPTS LLC
Model
1
Published
2025-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology
FERAnoscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
FERAnoscope And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242668000Gastro Concepts Air AssistGastro Concepts, LLC2024-12-13FER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012876808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012876808008600128768088600128768080860012876808

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope distal anchoring cuffA device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119470806
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
08033638802861Self-light anoscopesSAPI MED SPAFER2026-02-06
00860005357741CVAC Aspiration SystemCalyxo, Inc.FED2025-09-10
08051887044719THD N-Ano anoscopesTHD SPAFER2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
03600040995150ReTraceColoplast A/SFED2024-11-20
03600040995181ReTraceColoplast A/SFED2024-11-20
03600040995211ReTraceColoplast A/SFED2024-11-20
03600040995242ReTraceColoplast A/SFED2024-11-20
03600040995273ReTraceColoplast A/SFED2024-11-20
03600040995303ReTraceColoplast A/SFED2024-11-20
03600040995334ReTraceColoplast A/SFED2024-11-20
03600040995365ReTraceColoplast A/SFED2024-11-20
00860005357710CVAC Aspiration SystemCalyxo, Inc.FED2024-02-22
15019778008653OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008660OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008677OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
15019778008684OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFED2023-10-30
10860006600805AncoraAspero Medical, Inc.FED2023-10-26