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
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
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96973521878427BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878434BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878441BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878458BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878465BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878472BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878489BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878533BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878540BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878557BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878564BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878571BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878588BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878595BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878601BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878618BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878625BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878632BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878649BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
06976287180367Compression Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.JOW2026-07-10
00672736141649BREGBREG, INC.JOW2026-06-25
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
10193489024531MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18