FDA.reportPublic FDA data

Celon Wet Bands 66 x 120mm

Primary DI
10848530101821
Brand
Celon Wet Bands 66 x 120mm
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
WB66120
Device description
Celon Wets Bands 66x120mm
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530101824PrimaryGS10
10848530101821Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530101824008485301018248485301018240848530101824
1084853010182110848530101821

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23
00848530109240Oxygen, Bacteria & HEPA FilterOF9004BR2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterBF2200BR2026-06-23
00848530109110Suction KitRES026S-KITC2026-06-10
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592346652187Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652194Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652200Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652217Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652224Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692329Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692404Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692442Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692466Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692503Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346696914Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346705302Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346732926Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782013Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782020Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782075Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782655Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782723Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782730Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346815858Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893153Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893160Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893177Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893184Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893191Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893207Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905603Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905665Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997752Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997769Amvex FlowmeterGCE, s.r.o.CAX2026-07-07