FDA.reportPublic FDA data

BioTAB LLC

Primary DI
00199284566231
Brand
BioTAB LLC
Company
Biotab LLC
Model
PNCU-01
Device description
PnueAira Lymphedema Pump
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00199284566231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284566231001992845662311992845662310199284566231

GMDN Terms#

Term, Definition table
TermDefinition
Portable sequential venous compression systemA compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients.

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
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
00850078826091BioTAB LLCPNFL-TXL-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

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Primary DI, Brand, Company table
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