FDA.reportPublic FDA data

Bebe Keeper Kover

Primary DI
00815090010064
Brand
Bebe Keeper Kover
Company
SMALL BEGINNINGS INC
Model
16-3
Catalog number
16-3
Device description
The Bebe Keeper Kover is intended to be used as a universal cover for all sizes of Bebeonkers suction devices in between uses.
Published
2016-09-24
Public version status
Update
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
10815090010061PackageGS150In Commercial Distribution
20815090010068PackageGS16In Commercial Distribution
00815090010064PrimaryGS10
00815090012075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081509001006110815090010061
2081509001006820815090010068
00815090010064008150900100648150900100640815090010064
00815090012075008150900120758150900120750815090012075

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
002657679
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815090013409AP Onkers16-716-72022-12-15
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
00815090011382Bebeonkers II16-2KK16-2KK2016-09-24
00815090011535Webeonkers16-0KK16-0KK2016-09-24
00815090011740Bebeonkers I16-1KK16-1KK2016-09-24

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