DEVICE: NA (04055207057124)

Device Identifier (DI) Information

NA
8170202
In Commercial Distribution
8170202
Richard Wolf GmbH
04055207057124
GS1

1
315304071 *Terms of Use
INSUFFLATION TUBE F.2235021/031 L 3M high-flow with heating coil, for 100 reprocessing cycles, reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medical air low pressure tubing A length of flexible tube intended to conduct compressed medical air from a medical air cylinder/terminal unit to a medical device that functions with medical air (e.g., ventilators, anaesthesia units, anaesthesia systems, suctions systems and other medical air dependent devices). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is intended for use within a static clinical environment (e.g., intensive care), is colour-coded for medical air, and reinforced (e.g., with woven polyester or cotton). It is available in various lengths, including standard coil lengths. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HIF INSUFFLATOR, LAPAROSCOPIC
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000180 000
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 3 Meter
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Device Record Status

26a52c43-23de-414e-826b-01ec3991562a
July 06, 2018
3
September 23, 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
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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