FDA.reportPublic FDA data

n/a

Primary DI
00874750007189
Brand
n/a
Company
HANS RUDOLPH, INC.
Model
2600
Catalog number
113138
Device description
ELEV FIO2/2600 PER SMC SPEC
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CBPValve, Non-Rebreathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBPValve, Non-RebreathingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00874750007189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750007189008747500071898747500071890874750007189

GMDN Terms#

Term, Definition table
TermDefinition
Non-rebreathing valve, reusableA non-sterile device that is a one-way valve used to direct the flow of breathing gases and prevent the patient rebreathing the exhaled gases. It is typically used in a breathing system or between an oxygen mask and its reservoir bag. The device may be of various designs and will typically include unidirectional valves made of, e.g., silicone, rubber, metal, mica, sheets or discs that open and close for each inspiration/expiration. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007131725
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008171360277395530 3L SYRINGE55301139752026-05-01
008171360277465530 3L SYRINGE55301139762026-05-01
008171360277227450 RV2 MASK7450CC16412025-10-16
008171360277157450 RV2 MASK74502018412025-09-19
008171360272417450 RV2 MASK74506122212023-04-05
008171360272587450 RV2 MASK74506122442023-04-05
008171360272657450 RV2 MASK74506123992023-04-05
008171360272967450 RV2 MASK74506127812023-04-05
008171360273337450 RV2 MASK74506128642023-04-05
008171360273957450 RV2 MASK7450CC17342023-04-05
008171360274017450 RV2 MASK7450CC17482023-04-05
008747500027957450 RV2 MASK74502015192023-04-05
008171360276927450 RV2 MASK74501138822024-07-15
008171360277087450 RV2 MASK74501138852024-07-15
008171360270127450 RV2 MASK74501136932022-11-08
008171360268177450 RV2 MASK74501138832022-03-10
008171360268247450 RV2 MASK74501138842022-03-10
008171360267947450 RV2 MASK74501138052022-02-22
008171360267567450 RV2 MASK74501138012021-10-04
008171360262067450 RV2 MASK74501138552019-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B448260103XpectFirstar Healthcare Company Limited (Guangzhou)CBP2026-05-13
10889483570562AirLife™AIRLIFECBP2025-03-28
B0023000X0RescuerB.L.S. Systems LimitedCBP2023-12-11
09420012445261Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCBP2023-07-06
00634376498507(HEALTH & SAFETY INSTITUDE) HSI CPR REDI-SHIELD (Made in USA) with key ring caseRONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
00634376498576(HEALTH & SAFETY INSTITUTE) HSI CPR REDI-SHIELD with keyring case & gloves RONDEX PRODUCTS, INCORPORATEDCBP2023-01-02
0076658801349724M - Tampa Electric Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658802201724M - Salt River Project-21 - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588030111XLP - Toyota - Black - XLPouchCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588049045HSB - BBP - Southern Co.Certified Safety Manufacturing, Inc.CBP2022-07-15
0076658806057625M - First Aid Kit - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658806123824PW - Turtle Top Florida DOT - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588070650EMT Trauma Care - Red Cordovia BagCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658808074136M - Enbridge - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658809053510PC - Rail America Locomotive - PolyCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588090610Emergency Trauma Care Deluxe - Orange Co-Polymer CaseCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588100029Sports Bag - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810093710PW - Head Start - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588107042SB-2 - Head Start - Fanny PackCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658810957210M - Sempra - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658811012710PC - UP - 380-54620 - LocamotiveCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812001010M - State of South Dakota DOT BBP - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812068310PW - Hawaiian TelecomCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812072018PR - First Aid Complete Kit - Poly RedCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812082916PW - PCI Construction - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
00766588121079FAC-4 - Miller & Long ConcreteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658812966275V - UP Facilities - RefillCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813049136M - PacifiCorp - MetalCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658813058316PW - Los Alamos - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15
0076658814080310PW - RJ Corman - Poly WhiteCertified Safety Manufacturing, Inc.CBP2022-07-15