DEVICE: E.M. Adams Co, Inc. (10840200323922)

Device Identifier (DI) Information

E.M. Adams Co, Inc.
EP90408L-1
In Commercial Distribution

E.M. ADAMS, INC.
10840200323922
GS1

1
001403807 *Terms of Use
SAFETY VEST
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
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?
62482 Limb/torso/head restraint, reusable
A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMQ Restraint, Protective
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K971948 000
No CLOSE

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

[?]
Size Type Text
Device Size Text, specify: LARGE VEST/1.5" X 144" STRAP
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Device Record Status

2095c91b-756c-425a-a866-fa8040396762
May 20, 2022
1
May 12, 2022
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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
50840200323913 24 10840200323922 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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
772-461-0532
emadams@emadamsco.com
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