DEVICE: NormaTec (00810050281928)

Device Identifier (DI) Information

NormaTec
Normatec 3 Leg Attachment - Standard Power (Pair)/REJ6
In Commercial Distribution

NORMATEC INDUSTRIES LP
00810050281928
GS1

1
111448069 *Terms of Use
Normatec 3 Power Standard Pair Leg Attachment
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
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No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16837 Sequential venous compression system
A 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 applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.
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44768 Multi-chamber venous compression system garment, reusable
An 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.
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FDA Product Code

[?]
Product Code Product Code Name
IRP Massager, Powered Inflatable Tube
JOW Sleeve, Limb, Compressible
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K183328 000
K220217 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

169c3713-8a5b-4308-beb8-1da5aed4e351
July 29, 2024
2
June 16, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
Yes
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Customer Contact

[?]
No Customer Contact currently defined
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