FDA.reportPublic FDA data

BioTAB LLC

Primary DI
00850078826268
Brand
BioTAB LLC
Company
Biotab LLC
Model
PNVE-SL-01
Device description
STANDARD VEST GARMENT - Large
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00850078826268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078826268008500788262688500788262680850078826268

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.

Regulatory Flags#

DUNS number
557464257
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
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
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
00850078826084BioTAB LLCPNFL-TL-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
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
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22