ABS Nozzle

Primary DI
00869284000232
Brand
ABS Nozzle
Company
NIMBIC SYSTEMS, INC.
Model
Model 1002
Catalog number
ABS-1002
Published
2016-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORCAir Filter Portable Apparatus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORCAir Filter Portable ApparatusGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123006000AIR BARRIER SYSTEM (ABS)Nimbic Systems, Inc.2013-12-20ORC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869284000232PackageGS15In Commercial Distribution
00869284000201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869284000232008692840002328692840002320869284000232
00869284000201008692840002018692840002010869284000201

GMDN Terms#

Term, Definition table
TermDefinition
High-efficiency filter air cleaner, mobileA mains electricity (AC-powered) device that uses a combination of a prefilter and a high-efficiency particulate air (HEPA) filter to remove 99.97% of particles greater than 0.3 microns. This device is frequently used to prevent the transmission of tuberculosis (TB) and other diseases caused by airborne pathogens. It is designed to be moved from one location to another.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-565-5750info@nimbicsystems.com

Regulatory Flags#

DUNS number
868730834
Device count
1
DM exempt
false
Premarket exempt
false
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
00869284000201ABS NozzleModel 1002ABS-10022016-10-20
00869284000225ABS Velcro PadModel 4001ABS-40012016-10-20
00869284000249ABS Blower UnitModel 2002ABS-20022018-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842430115738HANA DISPOSA-PULL P-POST COVERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-05-31
00842430115455ABS HOOK AND LOOP PADMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115448AIR BARRIER SYSTEM STERILE NOZZLEMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115462AIR BARRIER SYSTEM BLOWERMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
00842430115745ABS HOOK AND LOOP PADMIZUHO ORTHOPEDIC SYSTEMS, INC.ORC2021-02-19
07350101640067Sterile ShieldToul Meditech ABORC2019-12-20
07350101640050Sterile ShieldToul Meditech ABORC2019-12-20
07350101640043SteriStayToul Meditech ABORC2019-09-05
07350101640005OperioToul Meditech ABORC2019-04-08
07350101640029Sterile ShieldToul Meditech ABORC2019-02-13
00869284000249ABS Blower UnitNIMBIC SYSTEMS, INC.ORC2018-11-15
00869284000201ABS NozzleNIMBIC SYSTEMS, INC.ORC2016-10-20
00869284000225ABS Velcro PadNIMBIC SYSTEMS, INC.ORC2016-10-20