AccessGUDID - DEVICE: Drägersorb 800 plus (5L) (04048675000020)

GUDID

Device Identifier (DI) Information

Brand Name: Drägersorb 800 plus (5L)
Version or Model: MX00001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drägerwerk AG & Co. KGaA

Primary DI Number: 04048675000020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 315578914 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42414	Carbon dioxide absorber, single-use	A non-sterile, prefilled, sealed container (i.e., a canister with connectors) that constitutes a complete anaesthesia absorber, which is intended to be placed in an anaesthesia unit/workstation breathing circuit for the removal of carbon dioxide (CO2) exhaled by the patient. It is filled by the manufacturer with an appropriate carbon dioxide absorbent (e.g., granules of treated soda lime) to chemically remove CO2. A drain may be included to channel water accumulated from expired-gas moisture or other source. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBL	Absorbent, Carbon-Dioxide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3db02117-fa07-4393-9120-01d4fd57da86
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 24, 2015

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04048675419969 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +494518820
Email: info@draeger.com

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