FDA.report

6100 NDGB

Primary DI
00817136023328
Brand
6100 NDGB
Company
HANS RUDOLPH, INC.
Model
6100
Catalog number
CR1727
Device description
CUSTOM 6100 100LTR NDGB NO VLV
Published
2018-11-08
Public version status
New
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

Product Codes

CodeName
BTCBag, Reservoir

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817136023328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817136023328008171360233288171360233280817136023328

GMDN Terms

TermDefinition
Exhaled-gas sample collector, non-electronicA container intended to collect a sample of a patient's exhaled gas for subsequent analysis. The container may be flexible or rigid and may have a soft disposable liner in which the sample is collected. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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