DEVICE: N/A (00607411917042)

Device Identifier (DI) Information

N/A
ZCC4121HP-1
In Commercial Distribution
ZCC4121HP-1
SALTER LABS
00607411917042
GS1

1
022721133 *Terms of Use
ComfortCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube
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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?
37326 Blood pressure cuff, single-use
A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXQ blood pressure cuff
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K921997 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

[?]
Size Type Text
Device Size Text, specify: Large Adult Long
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Device Record Status

54d15613-67be-43d8-87e5-50cd6f4e23d0
April 29, 2019
4
February 24, 2017
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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
10607411917049 10 00607411917042 In Commercial Distribution
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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

[?]
+1(800)421-0024
customercare@salterlabs.com
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