FDA.reportPublic FDA data

NURSE ASSIST, INC.

Primary DI
B15027600
Brand
NURSE ASSIST, INC.
Company
NURSE ASSIST, INC.
Model
2760
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSYCatheters, Suction, Tracheobronchial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842166000INTERMED, INS STERILE WATER/SALINEIntermed, Inc.1985-02-12BSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B15027600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy care kitA collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
869434464
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30850421008786Stericare64902026-03-12
30850421008830Stericare64802026-03-12
30850421008847Stericare64812026-03-12
00850421008976Stericare64902026-03-12
00850421008983Stericare648064802026-03-12
00850421008990Stericare64802026-03-12
00860013668501Stericare64912026-03-12
03085042100878Stericare64902026-03-12
10860013668508Stericare64812026-03-12
00850421008921NURSE ASSIST1210-SF2024-07-10
10850421008928NURSE ASSIST1210-SF2024-07-10
B1501210BP2NURSE ASSIST1210-BP2016-09-24
B1501210BP4NURSE ASSIST1210-BP2016-09-24
B15064927754SteriCare Solutions64927752024-02-08
00850421008907SteriCare Solutions52802024-02-08
00850421008914SteriCare Solutions52902024-02-08
00850421008198SteriCare Solutions52802024-02-08
00850421008891SteriCare Solutions52902024-02-08
B15064927750SteriCare Solutions64927752024-02-08
B15064927764Nurse Assist64927762024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated CatheterDynarex CorporationBSY2026-07-31
00840117351905Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351936Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351967Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117351998Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117352025Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
00840117352056Resp-O2 Single Suction Catheters, Adult Graduated Catheter, Control ValveDynarex CorporationBSY2026-07-31
04719874954611Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874957667Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
04719874958459Create BiotechCREATE BIOTECH CO., LTD.BSY2026-07-16
10889483564134BALLARD™SUNMED, LLCBSY2026-07-09
06925816656057Suction CatheterWell Lead Medical Co.,LtdBSY2026-06-03
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, Y-Adaptor, InfantDynarex CorporationBSY2026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-25
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, PediatricDynarex CorporationBSY2026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344266Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-05-18
00840117344747Resp-O2 Closed Suction Tracheal Catheter, Elbow, InfantDynarex CorporationBSY2026-05-18
00840117344754Resp-O2 Closed Suction Tracheal Catheter, Elbow, PediatricDynarex CorporationBSY2026-05-18
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10889483623565BALLARD™SUNMED, LLCBSY2026-01-16
00840117344136Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Adult/PediatricDynarex CorporationBSY2026-01-05
00840117344143Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, AdultDynarex CorporationBSY2026-01-05
00840117344167Resp-O2 Vexta72 Closed Suction Tracheal CatheterDynarex CorporationBSY2026-01-05
00840117344174Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05
00840117344181Resp-O2 Vexta72 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)Dynarex CorporationBSY2026-01-05