FDA.reportPublic FDA data

N/A

Primary DI
05030267037773
Brand
N/A
Company
Intersurgical Incorporated
Model
2310000
Device description
DUAL FLOAT AUTO FILL HUMIDIFICATION CHAMBER WITH FILL SET
Published
2020-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05030267037773PackageGS130In Commercial Distribution
05030267064151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267037773050302670377735030267037773
05030267064151050302670641515030267064151

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory line humidification chamber, single-useA device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
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
05030267169597SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430382026-04-21
05030267169634SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE11420352026-04-21
05030267056057Y-PIECE 22M, 22M, 22M/15F19000002021-10-12
05030267056095Y-PIECE 22M, 22M, 22M/15F WITH PORTS19010002021-10-12
05030267056118Y-PIECE 15M, 15M, 15F19020002021-10-12
05030267056132Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC19030002021-10-12
05030267056347PARALLEL Y-PIECE, 22MM19260002021-10-12
05030267056361PARALLEL Y-PIECE, 22M/15F -22M-22M WITH PORTS19270002021-10-12
05030267056408ADJUSTABLE Y-PIECE WITH SWIVEL NECK19290002021-10-12
00816472023726CO2 Sampling Line for Microstream® (Oridion®) capnography937160002023-01-13
05030267052257INTER-GUARD BREATHING FILTER WITH SUPERSET CATHETER MOUNT - STERILE1344711S2023-06-15
05030267054114CLEAR-GUARD3 ANGLED BREATHING FILTER WITH LUER PORT AND 22F/15M-22M/15F15450002023-06-15
05030267056279ONE-WAY DIRECTIONAL VALVE 22M FLOW IN-22F FLOW OUT19210002022-11-11
05030267057207T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES19540002023-06-15
0503026706065822MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M20260002025-03-14
0503026706071922MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M20263102025-03-14
05030267064823MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS27250002024-02-20