FDA.report

Gimmi

Primary DI
04049047116615
Brand
Gimmi
Company
Gimmi GmbH
Model
S.2930.00 II
Catalog number
S.2930.00 II
Device description
DUOLAP INSUFFLATOR 30 LTR. BASIC VERSION
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047116615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047116615040490471166154049047116615

GMDN Terms

TermDefinition
Laparoscopic insufflatorA mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.

Sterilization Methods

Method

Contacts

PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags

DUNS number
316152610
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04049047077077GimmiQO.1430.08QO.1430.082025-05-21
04049047077084GimmiQO.1430.14QO.1430.142025-05-21
04049047078005GimmiQO.2050.04QO.2050.042025-05-21
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