FDA.reportPublic FDA data

CARDINAL HEALTH ESSENTIALS

Primary DI
50885380102989
Brand
CARDINAL HEALTH ESSENTIALS
Company
RGH ENTERPRISES
Model
ZRSCK12
Catalog number
ZRSCK12
Device description
Cardinal Health Essentials; Suction Catheter Kit, Coil Packed; 5 Piece Kit; 12 Fr
Published
2019-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380102989PackageGS150In Commercial Distribution
00888499008543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088538010298950885380102989
00888499008543008884990085438884990085430888499008543

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal suction catheterA flexible tube typically made of plastic designed for periodic aspiration of liquids and/or semi-solids from a patient's upper airway. The tube is usually 40 to 56 cm (16 to 22 inches) in length and of small enough diameter to fit through an endotracheal (ET) tube. It usually has a smooth and rounded distal-tip configuration, including end and side holes; most include a finger-controlled valve to regulate the suctioning pressure. The device is externally attached through a large-diameter extension tube to a vacuum system and collection jar; it is used to remove excessive internal secretions from the lungs, bronchi, trachea, and pharynx. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049735438
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00888499000523RELIAMEDZGB235ZGB2352019-05-17
00888499000530RELIAMEDZGB410ZGB4102019-05-17
00888499000547RELIAMEDZGB414ZGB4142019-05-17
00888499000561RELIAMEDZGB44ZGB442019-05-17
00888499000578RELIAMEDZGB46ZGB462019-05-17
00888499000585RELIAMEDZGB48ZGB482019-05-17
00888499000592RELIAMEDZGB66ZGB662019-05-17
00888499000608RELIAMEDZGC44ZGC442019-05-17
00888499000615RELIAMEDZGC66ZGC662019-05-20
00888499000622RELIAMEDZGFB44ZGFB442019-05-17
10885380122712CARDINAL HEALTH ESSENTIALSZTDR02ZTDR022019-05-22
10885380122729CARDINAL HEALTH ESSENTIALSZTDR04ZTDR042019-05-22
10885380122736CARDINAL HEALTH ESSENTIALSZTDR06ZTDR062019-05-22
00885380122548CARDINAL HEALTH ESSENTIALSZTSC08ZTSC082019-04-22
00885380122555CARDINAL HEALTH ESSENTIALSZTPA05AZTPA05A2019-05-22
00885380122562CARDINAL HEALTH ESSENTIALSZTPL05AZTPL05A2019-05-22
00885380122579CARDINAL HEALTH ESSENTIALSZTCL05AZTCL05A2019-05-22
00885380122685CARDINAL HEALTH ESSENTIALSZTCL01AZTCL01A2019-05-22
00885380122692CARDINAL HEALTH ESSENTIALSZTCL02AZTCL02A2019-05-22
00885380122708CARDINAL HEALTH ESSENTIALSZTCL03AZTCL03A2019-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889483562611BALLARD™SUNMED, LLCBSY2025-11-21
10889483563861BALLARD™SUNMED, LLCBSY2025-11-21
10889483564370BALLARD™SUNMED, LLCBSY2025-11-21
10889483564424BALLARD™SUNMED, LLCBSY2025-11-21
10889483564479BALLARD™SUNMED, LLCBSY2025-11-21
10889483564486BALLARD™SUNMED, LLCBSY2025-11-21
10889483564554BALLARD™SUNMED, LLCBSY2025-11-21