FDA.reportPublic FDA data

BioTAB LLC

Primary DI
00850078826091
Brand
BioTAB LLC
Company
Biotab LLC
Model
PNFL-TXL-01
Device description
TALL FULL LEG GARMENT – X-LARGE
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251086000PnueAira (PNCU-01)Biotab, LLC2025-08-18JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078826091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078826091008500788260918500788260910850078826091

GMDN Terms#

Term, Definition table
TermDefinition
Multi-chamber venous compression system garment, reusableAn inflatable device in the form of a stocking, sleeve, or suit that is applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557464257
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199284566231BioTAB LLCPNCU-012025-09-18
00850078826015BioTAB LLCPNFL-SS-012025-09-18
00850078826022BioTAB LLCPNFL-SM-012025-09-18
00850078826039BioTAB LLCPNFL-SL-012025-09-18
00850078826046BioTAB LLCPNFL-SXL-012025-09-18
00850078826053BioTAB LLCPNFL-S2XL-012025-09-18
00850078826060BioTAB LLCPNFL-TS-012025-09-18
00850078826077BioTAB LLCPNFL-TM-012025-09-18
00850078826084BioTAB LLCPNFL-TL-012025-09-18
00850078826107BioTAB LLCPNFL-T2XL-012025-09-18
00850078826114BioTAB LLCPNCR-SS-012025-09-18
00850078826121BioTAB LLCPNCR-SM-012025-09-18
00850078826138BioTAB LLCPNCR-SL-012025-09-18
00850078826145BioTAB LLCPNCR-TS-012025-09-18
00850078826152BioTAB LLCPNCR-TM-012025-09-18
00850078826169BioTAB LLCPNCR-TL-012025-09-18
00850078826176BioTAB LLCPNYC-012025-09-18
00850078826183BioTAB LLCPNYC-U012025-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
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10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
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