FDA.reportPublic FDA data

Clearwand

Primary DI
00860009877818
Brand
Clearwand
Company
MORRIS MEDICAL, INC.
Model
CW1000
Device description
Rectal Cleansing System
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FHFSystem, Evacuator, Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009877818PackageGS15In Commercial Distribution
00860009877801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009877818008600098778188600098778180860009877818
00860009877801008600098778018600098778010860009877801

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111194428
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607915146498Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
00607915146504Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
03700512912101RocaFlow Endoscopy TubingPromeplaFHF2020-08-27
03700512922032Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512922049Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512922056Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512922063Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512922070Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512922087Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512921974Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
26939029815181SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
26939029815167MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815174MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
03700512921837Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512921868Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512921813Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spikePromeplaFHF2017-11-09
03700512921844Traxer Flow Dual Port - Irrigation set for Laser Ureteroscopy - 2 spikes PromeplaFHF2017-11-09
03700512921141Urology - TRAXERFLOW -2 Way Irrigation set Ureteroscopy with laserPromeplaFHF2016-11-24
03700512921653Urology - TRAXERFLOW -2 Way Irrigation set Ureteroscopy with laserPromeplaFHF2016-11-24
03700512921110Urology - TRAXERFLOW PromeplaFHF2016-10-25
03700512911029Laparoscopy - 1 Way Irrigation/Aspiration set (without handpiece & probe)PromeplaFHF2016-10-11
03700512911036Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip, PromeplaFHF2016-10-11
03700512921042Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)PromeplaFHF2016-10-11
03700512921059Laparoscopy - 2 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)PromeplaFHF2016-10-11
03700512911067Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ PromeplaFHF2016-10-11
03700512921073Gynecology - 1 way Hysterescopy setPromeplaFHF2016-10-11
03700512921080Gynecology - 1 way Hysteroscopy set with aspiration tubingPromeplaFHF2016-10-11
03700512921097Gynecology - 2 way Hysterescopy setPromeplaFHF2016-10-11
03700512921103Gynecology - 2 way Hysteroscopy set 2 spike with aspiration tubingPromeplaFHF2016-10-11
03700512921127Urology - TURP / POST OPERATIVE Irrigation/Aspiration set (WITH PUMP SEGMENT)PromeplaFHF2016-10-11