FDA.reportPublic FDA data

InHealth Technologies; Blom-Singer; EasyFlow

Primary DI
00848253002866
Brand
InHealth Technologies; Blom-Singer; EasyFlow
Company
Freudenberg Medical, LLC
Model
BE 1055EF
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848253002866PackageGS15In Commercial Distribution
00848253002842PrimaryGS10
00848253002859Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848253002866008482530028668482530028660848253002866
00848253002842008482530028428482530028420848253002842
00848253002859008482530028598482530028590848253002859

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-477-5969InHealth@inhealth.com

Regulatory Flags#

DUNS number
120981337
Device count
6
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
false
Expiration date on label
true
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
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-101PN1007960-1002026-01-29
00848253003948TruFit™ Adhesive Housing, 30 PackBE 60882025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackBE 6088-62025-04-01
00848253004013Cleaning Brush, StandardIN 4062IN 40622025-03-25
00848253004020Cleaning Brush, LongIN 4063IN 40632025-03-25
00848253004037StomaSoft Cleaning SwabsTSWB10SPT 0022025-03-17
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolSPT 002SPT 0022025-03-14
00848253002347InHealth Technologies; Blom-SingerTP 16082023-11-03
00848253002354InHealth Technologies; Blom-Singer®TP 16102023-11-03
00848253002361InHealth Technologies; Blom-Singer®TP 16122023-11-03
00848253002378InHealth Technologies; Blom-Singer®TP 16142023-11-03
00848253002385InHealth Technologies; Blom-Singer®TP 20082023-11-03
00848253002408InHealth Technologies; Blom-Singer®TP 20102023-11-03
00848253002606InHealth Technologies; Blom-Singer®TP 20122023-11-03
00848253003092InHealth Technologies; Blom-Singer®TP 20142023-11-03
00848253003115InHealth Technologies; Blom-Singer®TP 2208-LEF2023-11-03
00848253003122InHealth Technologies; Blom-Singer®TP 2210-LEF2023-11-03
00848253003139InHealth Technologies; Blom-Singer®TP 2212-LEF2023-11-03
00850004312001EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING668782-100PN1007960-1002021-06-15
00848253003665InHealth TechnologiesVP 2206-LEF2021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428798421OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
44710810101913N/AGALEMED CORPORATIONBYD2026-03-04
04710810101939N/AGALEMED CORPORATIONBYD2026-03-04
00810050855815ThermoFlo®TYPENEX MEDICAL LLCBYD2026-01-26
07331791181153Provox Life Oxygen (10 pcs)Atos Medical ABBYD2025-12-16
07331791181160Provox Life Oxygen (30 pcs)Atos Medical ABBYD2025-12-16
10848530107281Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.BYD2025-08-19
34026704928935GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928942GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928959GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928966GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928973GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928980GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704927457GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927467GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927740GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929010GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929024GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929031GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929492GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929522GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929536GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929720GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929864GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929041GIBECKTELEFLEX INCORPORATEDBYD2025-07-30
20884389976064MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
00848253003948TruFit™ Adhesive Housing, 30 PackFreudenberg Medical, LLCBYD2025-04-01
00848253003931TruFit™ Adhesive Housing, 6 PackFreudenberg Medical, LLCBYD2025-04-01