DEVICE: Dale IV Armor (H84106751)

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Device Record History
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Device Identifier (DI) Information
Dale IV Armor
675
In Commercial Distribution
675
Dale Medical Products, Inc.
H84106751
HIBCC

1
001061233 *Terms of Use
Dale IV Armor, Flexible protective overlay, Fits most.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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?
62997 Wearable percutaneous catheter/tube holder, non-sterile
A non-sterile device designed to fix a percutaneous catheter, tube, and/or drain (e.g., IV, epidural, or drainage catheter, GI tube) to a patient's body without suturing; it may in addition be intended for holding a non-surgically-invasive tube (e.g., nasogastric tube) to the patient (universal holder). It is designed as an adhesive pad, strip, or bandage that will attach to the patient's skin, sometimes with the exposed side having an integrated fixation mechanism (e.g., Velcro hook/loop closure) or a mechanical closure, to hold the catheter/tube in place. It may include transparent film for fixation site monitoring but it is not a film dressing. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KGX Tape And Bandage, Adhesive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Cool dry place
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b57803ac-f8f1-4054-a9aa-7fa19bc579bd
April 22, 2024
4
September 17, 2018
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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
H84106752 10 H84106751 In Commercial Distribution Box
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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
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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