BCI

GUDID 35019517053665

SMITHS MEDICAL MD, INC.

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 35019517053665
• NIH Device Record Key: 1c3b4b41-fc97-41ae-9654-505f75d2c513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BCI
• Version Model Number: 1163
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517053661 [Unit of Use]
GS1	35019517053665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991086

FDA Product Code

• CCK: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-10-13

On-Brand Devices [BCI]

• 00695085800210: 7204045
• 35019517062667: WW1100
• 35019517062254: WW8030
• 35019517062247: WW1131
• 35019517062230: WW1130
• 35019517062223: WW1129
• 35019517062216: WW1124
• 35019517062209: 124002
• 35019517062179: 124006
• 35019517054228: WW1140
• 35019517054143: WW3138
• 35019517053979: 1153B
• 35019517053955: 1149T
• 35019517053948: 1140M
• 35019517053931: 1140B
• 35019517053924: 1102P
• 35019517053894: 1101A
• 35019517053849: 125003
• 35019517053795: 9189
• 35019517053740: 8211
• 35019517053726: 8044
• 35019517053696: 3137
• 35019517053689: 1300
• 35019517053672: 1179
• 35019517053665: 1163
• 35019517053658: 1152
• 35019517053641: 1148
• 35019517053634: 1123
• 35019517053627: 1128
• 35019517053610: 1105
• 35019517042584: 3135
• 35019517042577: 3134
• 35019517042560: 3049
• 30843418001280: WW1021SYS
• 30843418001211: WW1030P1EN
• 30843418001204: WW1020P1EN
• 30843418001105: 3301A4
• 30843418001099: WW3078
• 30843418001082: 3301A2
• 30843418000849: 3301A1
• 30843418000818: WW1026SYS
• 30843418000801: WW1025SYS
• 30843418000757: WW1028SYS
• 30843418000740: WW1096SYS
• 30843418000375: WW1020A1EN
• 30843418000283: WW1000A1EN
• 30843418000191: WW1030EN
• 30843418000108: WW1020EN
• 30843418000016: WW1000EN
• 30610586038444: WW8214