FDA.reportPublic FDA data

CLEARline

Primary DI
04055146040843
Brand
CLEARline
Company
WILAmed GmbH
Model
BTS3301
Catalog number
270931
Published
2026-08-03
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
false

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055147000549PackageGS110In Commercial Distribution
04055147001362PackageGS150In Commercial Distribution
04055146040843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055147000549040551470005494055147000549
04055147001362040551470013624055147001362
04055146040843040551460408434055146040843

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
342827867
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
04055146040232CLEARlineBTS8342711912026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055146040232CLEARlineWILAmed GmbHJAY2026-08-03
04260217220141Oval Nooks-3G-1160-FS-O3Amtrion GmbHJAY2026-06-10
04260217222312Quick Lock-3G-912-M8-S2Amtrion GmbHJAY2026-06-10
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-06-01
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
04260217220318Circuit Support Arm ECOAmtrion GmbHJAY2026-03-30
04260217220479Vario Lock, Circuit Support Arm, 3 Joints, Bennet FootAmtrion GmbHJAY2026-03-30
10889483228579Capette™SUNMED, LLCJAY2025-12-31
20889483228576Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
20889483225469Septal-H™SUNMED, LLCJAY2025-12-16
10889483225431Septal-H™SUNMED, LLCJAY2025-12-15
10889483225448Septal-H™SUNMED, LLCJAY2025-12-15
10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00653658009019Marpac IncMarpac, Inc.JAY2025-06-06