FDA.reportPublic FDA data

AP Onkers

Primary DI
00815090013409
Brand
AP Onkers
Company
SMALL BEGINNINGS INC
Model
16-7
Catalog number
16-7
Device description
Adult/Pediatric oral/nasal suction device.
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815090013406PackageGS1100In Commercial Distribution
20815090013403PackageGS1600In Commercial Distribution
00815090013409PrimaryGS10
00815090013416Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001340610815090013406
2081509001340320815090013403
00815090013409008150900134098150900134090815090013409
00815090013416008150900134168150900134160815090013416

GMDN Terms#

Term, Definition table
TermDefinition
Airway device cleaning utensil, noninvasive, reusableA hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Centimeter

Contacts#

Phone, Email table
PhoneEmail
760-949-7707kelly@small-beginnings.com

Regulatory Flags#

DUNS number
002657679
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815090012426Tender and Tiny Tourniquets11TA11TA2020-08-03
00815090012464Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090010026Pacee Pacifier15A15A2020-09-24
10815090010023Pacee Pacifier15A15A2020-09-24
00815090010002Bili-Bonnet01A01A2020-08-03
00815090010019Bili-Bonnet01B01B2020-08-03
00815090010170Bili-Bonnet01C01C2020-08-03
10815090010009Bili-Bonnet01A01A2020-08-03
10815090010016Bili-Bonnet01B01B2020-08-03
10815090010177Bili-Bonnet01C01C2020-08-03
00815090012785Tender and Tiny Tourniquets11TA11TA2020-08-03
10815090012461Tender and Tiny Tourniquets11TH11TH2020-08-03
00815090011436Webeonkers16-016-02020-06-23
10815090011433Webeonkers16-016-02020-06-23
00815090010040Bebeonkers II16-216-22016-09-24
00815090010057Bebeonkers I16-116-12016-09-24
00815090010064Bebe Keeper Kover16-316-32016-09-24
00815090011382Bebeonkers II16-2KK16-2KK2016-09-24
00815090011535Webeonkers16-0KK16-0KK2016-09-24
00815090011740Bebeonkers I16-1KK16-1KK2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
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08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08