FDA.reportPublic FDA data

Hydro-Therm 3 HME with luer port, retainable cap and Flextube

Primary DI
00816472020282
Brand
Hydro-Therm 3 HME with luer port, retainable cap and Flextube
Company
Intersurgical Incorporated
Model
15606500
Device description
Hydro-Therm 3 HME with luer port, retainable cap and Flextube
Published
2023-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816472020299PackageGS120In Commercial Distribution
00816472020282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816472020299008164720202998164720202990816472020299
00816472020282008164720202828164720202820816472020282

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
315-451-2900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15M15111112026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15M15121112026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22F15131112026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22F15141112026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22F15151112026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22F15161112026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22F15171112026-06-10
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)82010302026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)82020302026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)82030302026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)82040302026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)82050302026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)82150302026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)82250302026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)89030302026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)89040302026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)89050302026-06-02
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10680651497588HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497595HalyardO&M HALYARD, INC.OFP2026-06-06
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10889483592748Vital Signs™AIRLIFEOFP2025-03-07
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10889483584118AirLife™AIRLIFEOFP2025-02-20
10889483584125AirLife™AIRLIFEOFP2025-02-20
10889483598207Vital Signs™AIRLIFEOFP2025-02-19
10889483592687Vital Signs™AIRLIFEOFP2025-02-18
10889483595145Vital Signs™AIRLIFEOFP2025-02-18
10889483595596Vital Signs™AIRLIFEOFP2025-02-18
10889483595855AirLife™AIRLIFEOFP2025-02-18
10889483595886AirLife™AIRLIFEOFP2025-02-18
10889483595909AirLife™AIRLIFEOFP2025-02-18
10889483597484Vital Signs™AIRLIFEOFP2025-02-18
10889483584330AirLife™AIRLIFEOFP2025-02-17
10889483584354AirLife™AIRLIFEOFP2025-02-17
10889483584361AirLife™AIRLIFEOFP2025-02-17
10889483584378AirLife™AIRLIFEOFP2025-02-17
10889483584385AirLife™AIRLIFEOFP2025-02-17
10889483596456Vital Signs™AIRLIFEOFP2025-02-17
10889483597699Vital Signs™AIRLIFEOFP2025-02-17
10889483600177Vital Signs™AIRLIFEOFP2025-02-17
10889483600320Vital Signs™AIRLIFEOFP2025-02-17
10889483592588Vital Signs™AIRLIFEOFP2025-02-13