FDA.reportPublic FDA data

Monitor System, IBC Base Unit

Primary DI
10851607003133
Brand
Monitor System, IBC Base Unit
Company
MEDSPIRA, LLC
Model
43T2631
Device description
Interactive Breath Hold - Monitor System, IBC Base Unit
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851607003133PackageGS15In Commercial Distribution
00851607003136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085160700313310851607003133
00851607003136008516070031368516070031360851607003136

GMDN Terms#

Term, Definition table
TermDefinition
Breath-hold system base stationA battery-powered component of a breath-hold system designed to electronically receive a patient's mechanical respiratory movements, detected by a patient belt, convert these to electronic values and wirelessly transmit signals to a remote display that is viewed by the patient for instruction on when and how long to hold their breath. This device may also function as a holder and a charger for multiple remote displays when connected to the main electrical supply.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-789-0013info@medspira.com

Regulatory Flags#

DUNS number
962187964
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
00851607003501mcompass Anorectal Balloon Expulsion CatheterRMD-003-001RMD-003-0012025-12-30
00851607003006QuikLinq FOB Adapter RMD-210-0202025-03-10
10851607003003QuikLinq FOB Adapter RMD-210-0202025-03-10
008516070035325-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
008516070035185-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
00851607003389System Accessory KitRMD-010-0112024-11-30
10851607003386System Accessory KitRMD-010-0112024-11-30
00851607003525Battery, Tablet PCRMD-010-0092024-11-30
00851607003235LED MonitorRMD-002-MON2021-07-01
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelRMD-002-0112023-10-06
00851607003372Medspira Tablet PC with Power SupplyRMD-010-0102023-10-06
00851607003396mcompass Anorectal Manometry SystemRMD-001U2023-10-06
00851607003419Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-packRMD-202-0072023-10-06
00851607003426Catheter, mcompass®, Biofeedback, 2-channel, 5-packRMD-202-0042023-10-06
00851607003433Extension Tube, mcompass® Catheter, 5-packRMD-202-0062023-10-06
00851607003440Extension Tube, mcompass® Catheter, 5-packRMD-201-0012023-10-06
00851607003457System, mcompass®, Anorectal Manometry RMD-2012023-10-06
00851607003464System, mcompass®, Anorectal Manometry RMD-201U2023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
G345SL2000CIONICCionic, Inc.HCC2026-06-04
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.HCC2026-04-22
04560340091749Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020896UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020902UltiumNoraxon U.S.A., Inc.HCC2026-03-30