DEVICE: Defibtech ACC Wrist Straps (00815098020669)

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Device Record History
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Device Identifier (DI) Information
Defibtech ACC Wrist Straps
RSS-1010
In Commercial Distribution

DEFIBTECH, L.L.C.
00815098020669
GS1

1
128340200 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
No
No
No
No

GMDN

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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?
44780 Cardiac resuscitator, line-powered
A mains electricity (AC-powered), external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRM Compressor, Cardiac, External
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K141809 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
f7fcb3e5-66eb-4037-82eb-84d78e1ea2fe
July 06, 2018
3
May 19, 2017
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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
20815098020687 3 00815098020669 In Commercial Distribution export configuration
10815098020680 1 00815098020669 In Commercial Distribution export configuration
10815098020673 1 00815098020669 In Commercial Distribution domestic configurati
20815098020670 3 00815098020669 In Commercial Distribution domestic configurati
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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