FDA.reportPublic FDA data

6100 NDGB

Primary DI
00874750008476
Brand
6100 NDGB
Company
HANS RUDOLPH, INC.
Model
6100
Catalog number
112377
Device description
6100 100 LITER NONDIFF GAS BAG
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

Product Codes#

Code, Name table
CodeName
BTCBag, Reservoir

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874750008476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750008476008747500084768747500084760874750008476

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277157450 RV2 MASK74502018412025-09-19
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360276855530 3L SYRINGE5530CR20972024-07-02
008171360276615570 3L SYRINGE55701136212023-11-08
008171360276545570 3L SYRINGE55701139272023-08-21
008171360276475570 3L SYRINGE55701139282023-08-17
008171360276307450 RV2 MASK7450CC16022023-08-11
008171360276237000 CONNECTORS7000CC17062023-06-14
008171360267637000 CONNECTORS7000CC20862023-06-13
008171360276167450 RV2 MASK7450CC21002023-04-13
008171360276092700 NRBV2700CR20872023-04-07
008171360270677450 RV2 MASK7450DR1320A2023-04-05
008171360270747450 RV2 MASK7450CC20812023-04-05
008171360270817450 RV2 MASK7450CC20822023-04-05
008171360270987450 RV2 MASK7450CC17432023-04-05
008171360271047450 RV2 MASK7450CC20512023-04-05
008171360271117450 RV2 MASK7450DR1320C2023-04-05
008171360271287450 RV2 MASK7450CC18592023-04-05
008171360271357450 RV2 MASK74502018302023-04-05

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20889483601737Vital Signs™AirLife Finland OyBTC2025-04-01
20889483620073Vital Signs™AirLife Finland OyBTC2025-04-01
20889483602505Vital Signs™AirLife Finland OyBTC2025-03-28
20889483602512Vital Signs™AirLife Finland OyBTC2025-03-28
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