FDA.reportPublic FDA data

BioTAB LLC

Primary DI
00850078826084
Brand
BioTAB LLC
Company
Biotab LLC
Model
PNFL-TL-01
Device description
TALL FULL LEG GARMENT – 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
00850078826084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078826084008500788260848500788260840850078826084

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
00850078826213BioTAB LLCPNFA-SS-012026-10-26
00850078826220BioTAB LLCPNFA-SM-012026-10-26
00850078826237BioTAB LLCPNFA-SL-012026-10-26
00850078826244BioTAB LLCPNVE-SS-012026-10-26
00850078826251BioTAB LLCPNVE-SM-012026-10-26
00850078826268BioTAB LLCPNVE-SL-012026-10-26
00850078826275BioTAB LLCPNSH-SS-01-L2026-10-26
00850078826282BioTAB LLCPNSH-SM-01-L2026-10-26
00850078826299BioTAB LLCPNSH-SL-01-L2026-10-26
00850078826305BioTAB LLCPNSH-SS-01-R2026-10-26
00850078826312BioTAB LLCPNSH-SM-01-R2026-10-26
00850078826329BioTAB LLCPNSH-SL-01-R2026-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078826213BioTAB LLCBiotab LLCJOW2026-10-26
00850078826220BioTAB LLCBiotab LLCJOW2026-10-26
00850078826237BioTAB LLCBiotab LLCJOW2026-10-26
00850078826244BioTAB LLCBiotab LLCJOW2026-10-26
00850078826251BioTAB LLCBiotab LLCJOW2026-10-26
00850078826268BioTAB LLCBiotab LLCJOW2026-10-26
00850078826275BioTAB LLCBiotab LLCJOW2026-10-26
00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
00850078826329BioTAB LLCBiotab LLCJOW2026-10-26
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
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