FDA.reportPublic FDA data

PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEM

Primary DI
00860014205507
Brand
PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEM
Company
Infinitus Medical Technologies LLC
Model
NUMA-GEN
Catalog number
NUMA-GEN
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014205507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014205507008600142055078600142055070860014205507

Regulatory Flags#

DUNS number
079575412
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003986844GENESIS BI-WING XL GEN 3.0FPLS-3000-XLFPLS-3000-XL2026-10-15
00860014205514TruBlu HDP Bootliners722060192026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning System722060172026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning System722060182026-06-05
00195893164608AXILLARY POSITIONING ROLLAXR-20002025-07-25
00195893397556AZUL, ITPWAZUL-20002025-07-25
00860006375959LUNA SUPINE PAD SYSTEMSP-35002025-07-25
00860006375966KIT, CHEST PAD AND STRAPCHST-30002025-07-25
00195893257713GENESIS BI-WING AAPFPLS-2000IHS-1T2:122024-07-17
00195893509492VISIWRAP SURGICAL FACE PROTECTORVWP-1000VWP-10002024-07-17
00860003986868GENESIS BI-WING AAP, XLFPLS-2100FPLS-21002024-07-17
00860003986875HADRON FPLS INFINITYFPLS-1000FPLS-10002024-07-17
00860003986882HADRON FPLS INFINITY, HDPFPLS-1000-HDPFPLS-1000-HDP2024-07-17
00860003986899HADRON FPLS INFINITY, XLFPLS-1100FPLS-11002024-07-17
00860006375904KYBER SCC OFFSET UNIVERSAL RETRACTION POST SYSTEMKSSC-1000-1KSSC-1000-12024-07-17
00860006375911ION ESPS ARM FIXATION SYSTEMIONESPS-20002024-07-17
00860006375928ION ESPS ARM FIXATION SYSTEMDP-01DP-012024-07-17
00860006375935ION ESPS ARM FIXATION SYSTEMFM02-IFFM02-IF2024-07-17
00860006375942ION ESPS ARM FIXATION SYSTEMFM03-IFFM03-IF2024-07-17
00860003986806GENESIS BI-WING APP GEN 3.0FPLS-3000FPLS-30002024-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588008417ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008424ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008431ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008448ULP Precise™Innovative Medical Products, IncCCX2026-11-05
00696588008455ULP Precise™Innovative Medical Products, IncCCX2026-11-05
05060624129049Face Cushy Set (Helmet + Mirror)CARE SURGICAL LIMITEDCCX2026-11-03
00787551041668LPK10037 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041675LPK10036 Lateral Positioning KitXODUS MEDICAL, INC.CCX2026-10-19
00787551041682SPK10756 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-10-19
00860003986844GENESIS BI-WING XL GEN 3.0Infinitus Medical Technologies LLCCCX2026-10-15
09421905187794Adept Medical Lateral Support SingleADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187800Adept Medical Lateral Support PairADEPT MEDICAL LIMITEDCCX2026-10-05
09421905187817Adept Medical Lateral Vacuum BraceADEPT MEDICAL LIMITEDCCX2026-10-05
15060797554775NADavid Scott CompanyCCX2026-09-25
00850047863799SurgiLockMedicalock CorporationCCX2026-09-24
00850047863829SurgiLockMedicalock CorporationCCX2026-09-24
00850047863836CerviLockMedicalock CorporationCCX2026-09-24
00749756401739DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-09-18
00848530109783Oxygen AccessorySunset Healthcare Solutions, Inc.CCX2026-09-09
00787551041637SPK11761 Jackson Table KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041644SPK11773 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00787551041651SPK11774 Surgical BackPack KitXODUS MEDICAL, INC.CCX2026-07-27
00851440007902Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.CCX2026-07-22
00811836030907TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00811836030921TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
20811836030215TrenGuard™Dan Allen Surgical LLCCCX2026-06-26
00860014205514TruBlu HDP BootlinersInfinitus Medical Technologies LLCCCX2026-06-05
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning SystemInfinitus Medical Technologies LLCCCX2026-06-05
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCCCX2026-05-31