DEVICE: Bioseal Inc. (00630094193960)

Device Identifier (DI) Information

Bioseal Inc.
19396/05
In Commercial Distribution

BIOSEAL
00630094193960
GS1

1
186968939 *Terms of Use
Weighted Blanket
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
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?
63637 Weighted duvet
A thick, weighted covering designed to be used to provide a patient with a sensation of gentle pressure/weight to improve sleep and/or provide comfort, while insulating the body for warmth. It is typically designed as two layers of material that envelop a weighted filling (e.g., polymer threads, silicone pellets) and may be available with a variety of insulating properties. It may be referred to as a weighted blanket and may be used on a bed or placed on the patient in other settings. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KME BEDDING, DISPOSABLE, MEDICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

efadf2f6-1507-448e-a035-626e502089f3
October 18, 2023
1
October 10, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10630094193967 5 00630094193960 In Commercial Distribution Case
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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