FDA.reportPublic FDA data

PCD Boot

Primary DI
00817369022396
Brand
PCD Boot
Company
NORMATEC INDUSTRIES LP
Model
4 Cell Standard Zippered Boot
Catalog number
20114
Device description
4 Cell Standard Zippered Boot
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K161346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161346000NormaTec PCD-T and PCD-BNormaTec Industries, LP2016-06-15JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817369022396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817369022396008173690223968173690223960817369022396

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
111448069
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050288743NormaTecNEH-252025-09-26
00810050281751NormaTecREJ62025-07-25
00810050288026Hyperice / NormaTecHX200012025-07-25
00810050288033Hyperice / NormaTecHX200022025-07-25
00810050281713NormaTecNormatec 3 Hose Attachment / REJ62024-07-26
00810050281812NormaTecNormatec 3 Right Arm Attachment/REJ62024-07-26
00810050281720NormaTecNormatec 3 Leg Attachment - Standard (Single)/REJ62023-06-16
00810050281768NormaTec Normatec 3/REJ6 Hip Attachment2023-06-16
00810050281782NormaTecNormatec 3 Arm Attachment (Pair)/REJ 62023-06-16
00810050281805NormaTecNormatec 3 Arm Attachment/REJ 62023-06-16
00810050281829NormaTecNormatec 3 Leg Attachment - Short (Single)/REJ62023-06-16
00810050281836NormaTecNormatec 3 Leg Attachment - Short (Pair)/ REJ62023-06-16
00810050281881NormaTecNormatec 3 Leg Attachment - Short Power (Single)/R2023-06-16
00810050281898NormaTecNormatec 3 Leg Attachment - Short Power (Pair)2023-06-16
00810050281911NormaTecNormatec 3 Leg Attachment - Standard Power (Single2023-06-16
00810050281928NormaTecNormatec 3 Leg Attachment - Standard Power (Pair)/2023-06-16
00810050281942NormaTecNormatec 3 Leg Attachment - Tall Power (Single)/ R2023-06-16
00810050281959NormaTecNormatec 3 Leg Attachment - Tall Power (Pair)/REJ62023-06-16
00810050282093NormaTec Normatec 3 Leg Attachment - Standard (Pair)/ REJ62023-06-16
00810050282116NormaTecNormatec 3 Leg Attachment - Tall (Single)/REJ62023-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489024500MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-05-18
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04719893351026WellellWellell Inc.JOW2026-03-17
08809802648494DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802648500DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
08809802646810DVT-2600DAESUNG MAREF CO.,LTD.JOW2025-12-19
08809802646858DVT-4000SDAESUNG MAREF CO.,LTD.JOW2025-12-19
10080196138302MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-14
10193489097252MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-10-13
10192253057775CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057782CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057799CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10192253057805CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
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10192253057829CARDINAL HEALTHCardinal Health 200, LLCJOW2025-05-07
10193489003154MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-04-17
10193489003161MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-21
10080196391974MEDLINE RENEWALMEDLINE INDUSTRIES, INC.JOW2025-03-18
10197344104543MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-03-11
10192253057768CARDINAL HEALTHCardinal Health 200, LLCJOW2025-02-19
10080196385409MEDLINEMEDLINE INDUSTRIES, INC.JOW2025-01-02
10192253016123Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016130Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10192253016185Kendall SCDCardinal Health 200, LLCJOW2024-12-16
10197344098415MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-12-02
10197344006687MEDLINEMEDLINE INDUSTRIES, INC.JOW2024-11-22
10192253057737CARDINAL HEALTHCardinal Health 200, LLCJOW2024-10-02
10885380184895CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184901CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25
10885380184918CARDINAL HEALTHCardinal Health 200, LLCJOW2024-07-25