FDA.reportPublic FDA data

TruBlu HDP Bootliners

Primary DI
00860014205514
Brand
TruBlu HDP Bootliners
Company
Infinitus Medical Technologies LLC
Model
840-00014
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00860014205514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014205514008600142055148600142055140860014205514

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014205521TruBlu HDP, Smith+Nephew Hip Positioning System840-000072026-06-05
00860014205538TruBlu HDP, Hana Hip Positioning System840-000082026-06-05
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
00860003986813HADRON FPLS INFINITY GEN 3.0FPLS-3000-PADFPLS-3000-PAD2024-07-16
00860003986837GENESIS BI-WING AAP WINGSET, GEN 3.0FPLS-3000-WING2024-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCCCX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCCCX2026-05-31
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05