FDA.reportPublic FDA data

Life2000

Primary DI
00887761978201
Brand
Life2000
Company
HILL-ROM SERVICES PTE. LTD.
Model
BT-20-0002
Device description
LIFE2000 VENTILATOR PACKAGED
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOUContinuous, ventilator, home use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170037000Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies2017-08-11CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761978201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761978201008877619782018877619782010887761978201

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
595156263
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887761997318The VitalCough®SystemM065632016-09-17
00887761997325The VitalCough®SystemPVC12016-09-17
00887761008038The Vest APX SystemM08368A2026-03-18
00887761008045The Vest APX SystemM08368W2026-03-18
00887761976849The Vest®SystemP3006000052024-12-20
00887761984561Volara SystemM085732020-05-14
00887761985018Volara SystemM080852020-03-10
00887761967243The Vest APX SystemM084632024-09-06
00887761967366The Vest APX SystemM083682024-09-06
00887761967373The Vest APX SystemM083672024-09-06
00887761973473Life2000RMS010125CP2024-02-13
00887761974739Life2000BT-80-0008A2024-05-24
00887761981690Volara SystemM08594A2023-11-28
00887761984615Maximus SystemM082492020-03-06
00887761979048Life2000BT-80-00052024-02-13
00887761981492Volara SystemM084732020-03-04
00887761997608The Vest®SystemP3002810012016-09-17
00887761997332The MetaNeb®System1917742016-09-17
00887761997523The Vest®SystemP3002920012016-09-17
00887761997844The Vest®System5003700062016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NOU2025-12-02
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NOU2025-08-06
00850018761383VOCSN Passive ValveVentec Life Systems, Inc.NOU2024-12-02
00619498291410AstralRESMED PTY LTDNOU2023-07-26
00855573007822VOCSNVentec Life Systems, Inc.NOU2023-06-30
07290017856728Roll Stand for use with ventilatorsFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-06
07290017856698 Test Lung KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856704 Test Lung Quick Release KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856711Quick Release KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856735Ventilator 3 Section Arm with ExFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856742Carrying CaseFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856759Rail Mount KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07290017856766O2 KitFLIGHT MEDICAL INNOVATIONS LTDNOU2022-09-02
07321820021857Vivo 50, Vivo 65, Vivo 45 LSBreas Medical ABNOU2022-06-18
07321820035229Vivo 45 LSBreas Medical ABNOU2022-06-18
07321820045594Vivo 50, VIvo 65Breas Medical ABNOU2022-06-18
00855573007761VOCSNVentec Life Systems, Inc.NOU2022-04-12
00855573007785VOCSNVentec Life Systems, Inc.NOU2022-04-12
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.NOU2022-03-23
00850018761154VOCSNVentec Life Systems, Inc.NOU2021-04-30
00850018761161VOCSNVentec Life Systems, Inc.NOU2021-04-30
00850018761130VOCSNVentec Life Systems, Inc.NOU2021-03-03
00850018761116VOCSNVentec Life Systems, Inc.NOU2021-02-23
00850018761109VOCSN High Flow KitVentec Life Systems, Inc.NOU2021-02-23
00606959055483Trilogy EvoRespironics, Inc.NOU2021-02-12
00606959062863Care Orchestrator EssenceRespironics, Inc.NOU2021-02-09
00606959051980Trilogy EvoRespironics, Inc.NOU2021-01-22
00606959060449Care Orchestrator Essence SoftwareRespironics, Inc.NOU2021-01-22
00619498003259Astral 100RESMED PTY LTDNOU2021-01-08
00619498003266Astral 150RESMED PTY LTDNOU2021-01-08