DEVICE: N/A (00607499991255)

Device Identifier (DI) Information

N/A
1230-0
Not in Commercial Distribution
1230-0
SALTER LABS
00607499991255
GS1
October 01, 2018
1
022721133 *Terms of Use
Pocket Peak - standard range. 1230-0 part number taken out of commercial distribution Correct part number 1230 DID is 00607411001253, already in system.
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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?
46872 Peak flow meter, manual
A manual, hand-held instrument designed to measure only the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] from the lungs. It typically includes a tube for patient exhalation, an easy-to-grip handle, and a calibrated scale that shows the value of the peak flow. The device helps to discriminate the pulmonary status in routine tests performed in or outside of a clinical setting; it is also intended for periodic self-evaluation of the respiratory status of a patient, and to help in the treatment evaluation of patients suffering from chronic respiratory disorders (e.g., asthma, emphysema).
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
BZH METER, PEAK FLOW, SPIROMETRY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K952713 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius
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Clinically Relevant Size

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

97de736e-d0a5-4385-899f-e1f19183d227
May 11, 2020
5
September 24, 2016
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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
No Package DIs found
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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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