DEVICE: PFT Kit I, VBMax31S (00817081027570)

Device Identifier (DI) Information

PFT Kit I, VBMax31S
PFT Kit I, VBMax31S - 187121
In Commercial Distribution
187121
A-M SYSTEMS, LLC
00817081027570
GS1

1
020275145 *Terms of Use
Pulmonary Function Test Kit I, VBMax31S, with White Foam Nose Clip & Rubber Mouthpiece
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
60506 Pulmonary function testing kit
A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAH Filter, Bacterial, Breathing-Circuit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000654 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
No Device Sizes
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Device Record Status

b212436c-445a-4ef9-b046-575477bfb6c3
May 25, 2023
1
May 17, 2023
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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
00817081027587 100 00817081027570 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
Yes
No CLOSE

Customer Contact

[?]
3606838300
sales@a-msystems.com
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