FDA.report

n/a

Primary DI
00874750006038
Brand
n/a
Company
HANS RUDOLPH, INC.
Model
6900
Catalog number
112025
Device description
SALIVA COLLECTOR MPORT LG 6986
Published
2016-09-16
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

Product Codes

CodeName
CBPValve, Non-Rebreathing

Product Code Classifications

CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00874750006038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750006038008747500060388747500060380874750006038

GMDN Terms

TermDefinition
Pulmonary function valveA non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test gases. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
DM exempt
true
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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