FDA.reportPublic FDA data

NeoPod T, Neonatal Transport Humidification System

Primary DI
00850018561839
Brand
NeoPod T, Neonatal Transport Humidification System
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
Universal, NeoPod "T" Breathing Circuit Neonatal T
Catalog number
9403U
Device description
Universal, NeoPod "T" Breathing Circuit Neonatal Transport Circuit, w/ Exhalation Valve and LavaBed Cartridge
Published
2026-10-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018561839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018561839008500185618398500185618390850018561839

Contacts#

Phone, Email table
PhoneEmail
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
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
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
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Delivery Lines415-00012026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Sample Lines415-00002026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Bagger415-00022026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Bagger731-99192026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx NO Supply Hose731-18622026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Kit731-02742026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Test Circuit738-18892026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Circuit738-18502026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Kit731-91472026-10-19
00850018561006ECG Patient CableECG Patient Cable711-00142026-10-13
00850018561037Gel-E DonutGEL-E DONUT, MEDIUM (CASE OF 12)9898031963912026-10-13
00850018561044Gel-E DonutGEL-E DONUT, EXTRA SMALL (CASE OF 12)9898031963712026-10-13
00850018561051Gel-E DonutGEL-E DONUT, SMALL (CASE OF 12)9898031963812026-10-13
00850018561068SquishonSquishon 2 Gel Pillow, 12/pk9898031963612026-10-13
00850018561075SquishonSquishon Mattress9898056033012026-10-13
00850018561082SquishonSquishon 3 Gel Pillow, 12/pk9898056064612026-10-13
00850018561105WeeSpecsWeeSpecs, Small (28-34 cm), 50/pk9898056076412026-10-13
00850018561136WeeSpecsWeeSpecs Supreme Small, 50/pk9898056041612026-10-13
00850018561143WeeSpecsWeeSpecs Supreme, Medium, 50/pk9898056042112026-10-13
00850018561150WeeSpecsWeeSpecs Supreme, Preemie, 50/pk9898056076312026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561617NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561716NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561723NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561730NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561785NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561792NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561808NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561815NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561822NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561846NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561853NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561860NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 mlAIRLIFEBTT2025-02-20